Total 51 site clerk job vacancies in Quality Assurance / Control category in The United States of America

ROLE RESPONSIBILITIES

• The reviewing of site purchase orders to ensure that the applicable requirements are met
• The control of on site and off site vendor inspectors
• The compilation of vendor inspection assignments packages
• The coordination and resolution of any nonconforming product Reviewing vendors QA/QC systems in accordance with contractual requirements
• The attendance at site and inspection procurement meetings
• Coordination of vendor quality approvals when required
• Ensure the verification of documentation and certificates for materials purchased by vendors
• Review of suppler quality plans against contract requirements
• Review procurement documents to ensure that quality requirement have been correctly translated into purchase requisitions and design documents
• Review supplier inspection procedures and personnel qualifications
• Review supplier material certificates
• Take part in supplier audit and surveillances
• Coordinate with the companies discipline engineers for the resolution of technical discrepancies
• Coordinate with management for quality improvements
• Issue of nonconformance reports
• Track all nonconformance reports
• Coordinate with the owners representative on all procurement issues
• Monitor progress of all purchase requisitions

Working Hours: Monday to Saturday, 9 am to 6 pm.

May need to work on Sundays if required.

Cricut is seeking an experienced and versatile Supplier Quality Engineer to join our Global Quality Engineering team in Johor Bahru, Malaysia. As a Supplier Quality Engineer, you will use your experience, expertise, and resourcefulness to identify analyze and solve problems, develop goals and objectives to meet short-term and some long-term quality goals. The SQE will also focused on supplier quality management in a contract manufacturing setup, working to monitor supplier performance, and drive improvements to reduce the number of defects and Cost of Quality and ensure a world class customer experience. You should be able to drive the projects independently, represent QA concerns in meetings with cross-functional, project team and with contract manufacturing partners.

Responsibilities

• Ownership of supplier quality control & management process at contract manufacturing & supplier facilities with a strong focus on continuous improvement of quality system.
• Develop and maintain a robust supplier quality system including incoming/in-process/outgoing inspection (IQC, IPQC, FAI, OQC) requirements, Cricut Pre Shipment Buy Off, yield tracking/improvement, CAPA systems and supplier audit schedules.
• Perform periodic process audits and parts or finished products audits at Contract Manufacturing or Supplier site.
• Work closely with internal quality and sourcing resources to manage supplier audits, and maintain supplier score cards to drive improvements for quality, cost, service, and delivery
• Maintain appropriate quality database and report supplier performance on a monthly basis.
• Work with suppliers to assure “zero defect” performance through root cause evaluation and driving corrective actions using Quality tools such as 8D, FMEA, poke yoke and control plans.
• Responsible for SCAR from initiation to closure
• Drive supplier selection through robust qualification processes and assist in qualification of parts, production line, fixtures and go-no gages at CM and supplier locations.
• Work effectively with product management, engineering, and sourcing teams to eliminate any barriers that may affect the quality and delivery of sourced components/products.

We are at the heart of every place that matters. As a leading global provider in the access solutions market for schools, banks, airports, hospitals, hotels, and many more, we enable seamless movement within secure, safe, and sustainable places. Our work is IMPORTANT. YOU are important. We provide our people with the tools to shape their careers for growth. With around 16,000 employees worldwide, EVERY team member contributes to our mission and can make a positive difference. By working as one global team, we continue growing the business, growing together, and growing ourselves. Build your career with us! Site Compliance Representative Hallam, VIC, AU, 3803 Apr 4, 2024 THIS OPENS THE DOOR TO YOUR FUTURE: OUR OPPORTUNITY We have a great opportunity for a Site Compliance Representative to join our Sales Team based in Hallam. Within this role you will work collaboratively with the State Sales Team as well as other internal and external stakeholders…

Click here to view more detail / apply for Site Compliance Representative

Your new company
You will be working for a well established contractor with multiple live sites across the North West area.
Your new role
Exciting new construction project in Cheshire. Steel Frame. You will provide effective management of Quality Assurance and Control to the project team with the company's Business Management System. 47.5 - 66.5 hours per week depending on project requirements. 9.5 hours Monday to Friday (9.5 hours Saturday and Sunday as required).
Duties:
- Work with the Project Manager and others to ensure the business maintains its ISO 9001: 2015 certification by leading, promoting, and developing a positive Quality culture.
- Assist Project Manager, Construction Manager and project team with the implementation of project specific Quality documents, e.g. Project Quality Plans, Inspection & Test Plans, etc
- Undertake regular quality audits at site and produce relevant reports whilst investigating and reporting on Quality incidents.
- Monitor "close out" of corrections and preventive/ corrective actions of non-conformances.
- Monitor corrective actions.
- Support our project team through interaction with management and delivery teams and their supply chain.
- Participate in client Quality initiatives, forums and working groups.

What you'll need to succeed
- 5 years minimum experience in a construction environment
- A knowledge and understanding of ISO 9001
- An understanding of audit and inspection processes for construction projects and the ability to communicate their value and benefits to the rest of the company.
- An understanding of the lifecycle of projects and where quality interfaces.
- The ability to follow business and function processes and work in an organised manner.
- Good team working skills as well as the drive to work on your own.
- Experience in construction works and/or in the structural steelwork industry.


What you need to do now


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Summary
The Customer Service Coordinator will support the shop management process through timely customer communications and scheduling, inventory ordering and stocking, repair follow-up and maintenance file management.

Essential Functions

• CUSTOMER SERVICE:
  Improve the quality and consistency of customer communications and meet customer's expectations.
  Perform customer relationship activities to include customer interface, issue resolution and customer satisfaction.
  Execute customer communication protocol pertaining to PM scheduling and follow-up, breakdowns and vehicle status updates.
  Improve the quality and consistency of customer communications and ensure customer's expectations are met.
  Drive improvement of Customer Satisfaction (CSI) scores.

• WORKFLOW MANAGEMENT:
  Enhance branch productivity through effective work scheduling and planning.
  Create repair order tasks and update work planning sheet.
  Review maintenance reports to identify and schedule preventative maintenance, repair campaigns and vehicles requiring follow-up.
  Coordinate with rental counter to identify repair requirements, available substitute units and vehicle wash requirements.
  Coordinate outside repair with vendors and customers.
  Provide a resource that allows the management team time to effectively manage shop operations.

• PARTS MANAGEMENT:
  Contribute to cost containment through effective inventory planning and warranty.
  Execute parts inventory management processes to include conducting physical inventory, parts ordering, receiving, stocking, managing purchase orders and parts invoice and coordinating parts pick-up and delivery.
  Make recommendations on min-max levels to the inventory planning team.
  Manage parts obsolescence.
  Ship warranty and return parts.
  Organize and ensure cleanliness in the parts room.

• ADMINISTRATIVE:
  Effectively handle all incoming shop calls
  Clerical duties within the shop operations which include vehicle maintenance files.
  Process all Account Payable.
  Create repair orders for technicians.

Additional Responsibilities

• Contribute to cost containment through effective inventory planning and warranty.

• Enhance branch productivity through effective work scheduling and planning.

• Performs other duties as assigned.

Skills and Abilities

• Detail oriented with excellent follow-up practices.

• Strong verbal and written communication skills.

• Apply effective phone skills.

• Capable of multi-tasking, highly organized, with excellent time management skills.

• Flexibility to operate and self-driven to excel in a fast-paced environment.

• Ability to create and maintain professional relationships within all levels of the organization (peers, work groups, customers, supervisors).

• Ability to work independently and as a member of a team.

• Experience using Microsoft word and excel intermediate preferred.

Qualifications

• H.S. diploma/GED required General H.S. subjects.

• One (1) year or more customer service or comparable experience with issues resolution experience required.

DOT Regulated
No

The hourly rate for this position ranges from $18-$20 an hour.

Job Category

Operations and Support

Ryder is proud to be an Equal Opportunity Employer and Drug Free workplace. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Current Employees:

If you are a current employee at Ryder (not a Contractor or temporary employee through a staffing agency), please click here to log in to Workday to apply using the internal application process.

Overview: I'm happy to announce my partnership with a global leader in renewable energy in seeking a dedicated and experienced Site Quality Engineer to join their dynamic team. My client is committed to delivering innovative and reliable solutions for a cleaner future and currently working on a one-of-a-kind project in the coast of NSW. If you are passionate about quality assurance and eager to contribute to cutting-edge projects in the renewable energy sector, we want to hear from you. Position: As a Site Quality Engineer specializing in BESS, you will play a pivotal role in ensuring the highest standards of quality and compliance throughout the project lifecycle. Duties and Responsibilities ... Overview: I'm happy to announce my partnership with a global leader in renewable energy in seeking a dedicated and experienced Site Quality Engineer to join their dynamic team. My client is committed to delivering innovative and reliable solutions for a cleaner future and currently…

Click here to view more detail / apply for Quality Site Engineer

This role will be based at our Taiwan Manufacturing plant. Relocation and Immigration Assistance will be provided to the successful candidate.

Join us as we elevate standards and redefine quality assurance in our dynamic manufacturing environment. Lead our team to new heights as our Site Quality Head and drive excellence every step of the way.

Reporting to the VP of Quality, you will speahead our site's quality initiatives,ensuring uncompromising standards and driving continuous improvement across all operations while cultivating a "Quality Always" mindset throughout the organization.

Responsiblities:

• Lead the Quality Assurance team, covering operational quality, quality systems, and compliance, along with managing the Quality Control team. Responsible for staffing, training, and fostering the development of the Quality organization.
• Supervise all GXP activities at the Lotus Taiwan site, overseeing manufacturing, testing, release, facility, and utilities to maintain compliance with cGMP.
• Ensure adherence to regulatory requirements, including US FDA, EU, PIC/S, and TFDA standards, and drive continuous enhancement of Lotus Quality systems.
• Conduct and oversee quality audits, both internal and external, and manage responses. Act as the host for customer and regulatory audits at the Lotus Taiwan site.
• Serve as the primary interface with Quality Personnel and external stakeholders on quality-related matters.
• Manage batch disposition, recalls, and complaints, including handling product quality complaints and adverse events.
• Direct the process of new product introduction, technology transfer, and support for product registrations.
• Oversee supplier and third-party management, ensuring compliance with quality standards, particularly for contract manufacturing and laboratories.
• Handle the budget, headcount, and capital expenditure of the Quality department.
• Provide quality oversight for Good Distribution Practice in the Lotus Taiwan commercial operations.
• Manage quality aspects for in-licensed products in the Taiwan market.
• Fluency in Mandarin is a must to communicate to the manufacturing environment.

Requirements

• Candidate should possess a minimum 10 years of experience in quality assurance and quality control in the pharmaceutical industry.
• Strong knowledge of Goods Manufacturing Practices (GMP) and other regulatory requirements including US FDA, EU PIC/S and TFDA regulations.
• Proven experience in managing GXP activities, including manufacturing, testing, release, facility and utilities.
• Experiece in leading and managing quality audits, both internal and external and responding to audit findings.
• Excellent understanding quality systems and continuous improvement methodologies.
• Demostrated ability to manage and resolve product quality complaints, adverse events, and recalls.
• Experience in managing budgets, headcount, and capital expenditure within a quality department.

If you are interested in this opportunity, please send your resume to jean.chien@lotuspharm.com.

Job Description

Join our esteemed pharmaceutical company based in Friesoythe, committed to advancing healthcare through innovation and quality. We specialize in the research, development, and distribution of life-saving medicines and vaccines. As a vital member of our team, you'll play a crucial role in ensuring compliance with global regulatory standards and driving continuous improvement in quality and operational excellence.

As the Lead of the Site Quality Unit you will be responsible for a team of about 85 employees. Aditionally, the position is part of the Site Leadership Team and provides strategic Quality direction to the Site team (about 400 People) to ensure compliance of manufacturing, testing and release with all applicable regulations including FDA and EU GMP requirements. The positions ensures also the operational needs for testing and releasing of products according to aligned schedule.

Requirements:

• Education: Pharmacist, or similar/equivalent scientific university degree in Chemistry or Biology
• Minimum ten (10) years of experience in Pharmaceutical or Vaccine Operations, Technology, and/or Quality Operations
• An understanding of aseptic techniques and GMP requirements for aseptic processing is mandatory
• Knowledgeable of GMP compliance and conversant with domestic and foreign regulations compendia governing plant operations – FDA experience required
• Knowledgeable of analytical, chemical, and microbiological methods, instruments, and IT systems
• Have strong leadership skills and demonstrated ability to motivate / mentor others to achieve results
• Excellent facilitation, verbal and written communication skills
• Ability to plan, prioritize, and effectively manage projects and programs independently
• Ability to work effectively in a team environment and todrive changes in the team
• Technical / analytical data comprehension
• German proficiency

Key responsibilities:

Quality and Compliance:

• Provide strategic Quality direction to the site team
• Ensure all GMP compliance activities are coordinated, prioritized, and completed in accordance with approved procedures
• Remain abreast of and assure GMP compliance with applicable worldwide regulatory standards
• Responsible for all testing and release activities including raw materials, components, intermediates and final product
• Responsible for the Quality management systems (documentations, deviations, complaints, CAPA, change controls, audits, PQR, Quality supplier management, Quality Risk Management, TQA…)
• Ensure the right Quality Metrics are measured at the right tier levels including Site Quality Council to oversee the quality systems and maintain the site in a state of control and permanent inspection readiness
• Monitor the performance of product and processes and recommend strategic direction for continuing enhancements to quality and customer service.
• Manage authority inspections and divisional audits for pre-inspection assessments
• Oversee and execute all applicable market actions and related investigations/regulatory notifications consistent with regulatory requirements
• Assure the preparation and timely submission Health Authority notifications to appropriate regulatory authorities
• Develop and implement the Site Annual Quality Plan and Quality Improvement Plans (as required)
• Provide quality expertise for capital project initiatives and ongoing project work
• Support production, quality and technology initiatives. Represent Quality on cross-functional teams to ensure alignment to our Policies & Guidelines and regulatory requirements

Organizational and People Development:

• Drive to ensure organizational fitness in terms of having the right capacity and capabilities avaialable
• Ensure continuous development of talent through coaching and development plans for the Quality talents
• Ensure a site culture of site culture of speaking up
• Embrace diversity and inclusion in both the Site Quality and across the plant site
• Ensure people within the organization have the appropriate GMP training

Financial

• Responsible to establish the yearly budget and to ensure adhearance.
• Drive Operational Excellence and continuous improvement to improve effectiveness and productivity of operational Quality tasks

Safety

• Ensure compliance to all established safety procedures and practices and completion of all required safety training

Our Benefits:

• Flex Time (37.5 hours/week)
• Attractive compensation package (13 monthly salaries plus target bonus)
• Company pension plan
• Vacation allowance (1.200€ annually)
• 30 days annual leave
• Employee benefits
• Company bike / bicycle leasing
• Additional payment for Hansefit (Fitness Membership)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Site Compliance Manager (m/w/d)

an unserem Standort in Freiburg, zunächst befristet für zwei Jahre

Freiburg ist unsere weltweit größte Produktions- und Verpackungsstätte für feste Arzneimittel. Es werden derzeit über 6 Milliarden Tabletten und Kapseln produziert und an Patient:innen auf der ganzen Welt geliefert.

Das erwartet Sie:

Sie werden Teil der Qualitätsorganisation und bekleiden hierbei eine spannende Schnittstellenfunktion und sind für die Einhaltung der regulatorischen Compliance für Kundenprodukte am Standort zuständig. Sie arbeiten sowohl standortintern als auch mit Kunden, anderen Standorten und globalen Teams zusammen.

• Arbeit mit relevanten Teilen von Zulassungsdokumenten (Common Technical Documents), Sicherstellen der Einreichungskonformität mit den entsprechenden Vorgaben sowie der termingerechten Abwicklung
• Betreuung von Projekten im Bereich Site Compliance unter Erreichung der projektspezifischen Zielvorgaben hinsichtlich Regulatory Compliance
• Verantwortlich für Struktur, Planung sowie Erstellung der richtigen Dokumente unter Berücksichtigung vorgegebener Termine und die Koordination aller anfallenden Aktivitäten mit Kunden und den verschiedenen Abteilungen wie Produktion, Abpackung und Qualitätskontrolle
• Bearbeitung und Beantwortung von Anfragen interner und externer Kunden
• Beteiligung u.a. am Change Management (intern und global), den periodischen Produktreviews und den Produkttransfers

Das bringen Sie mit:

• Naturwissenschaftliches Hochschul- oder Fachhochschulstudium oder Nachweis der entsprechenden Qualifikation
• Erfahrung im Bereich der Zulassung von Arzneimitteln/Regulatory Compliance wünschenswert
• Kenntnisse des aktuellen regulatorischen und arzneimittelrechtlichen Umfeldes wünschenswert
• Kenntnisse in pharmazeutischer Analytik und Technologie
• Gute Englischkenntnisse sowie sehr gute Deutschkenntnisse
• EDV-Kenntnisse gängiger Software (z.B. Office, SAP, Trackwise)
• Klare verbale und schriftliche Kommunikation

  

Gemeinsam stehen wir für: 

Breakthroughs that change patients' lives – Um unseren Unternehmenszweck zu erfüllen, leitet eine wertorientierte Unternehmenskultur unser Handeln. Pfizers Werte sind: Courage, Excellence, Equity & Joy.

Courage: Eine mutige Art und Weise, wie wir unsere Ziele erreichen, ist unsere unternehmensweite Strategie der digitalen Transformation. Unsere flachen Hierarchien ermöglichen kurze Entscheidungswege.

Excellence: Wir fokussieren uns auf das, was wirklich wichtig ist, übernehmen Verantwortung, messen Fortschritte und arbeiten vertrauensvoll zusammen. Gemeinsam setzen wir auf eine agile Arbeitsweise, die unsere Mitarbeiter:innen dazu ermutigt, sowohl ihr Privat- und Arbeitsleben in Einklang zu bringen als auch die persönliche Weiterentwicklung voranzutreiben. 

Equity: Wir sind davon überzeugt, dass unterschiedliche Erfahrungen wertvoll sind, weshalb jede Meinung gehört und wertgeschätzt wird. Diese Erfahrungen und Meinungen bereichern das gesamte Unternehmen. So fördern wir ein vielfältiges und inklusives Arbeitsumfeld in dem sich Kolleg:innen in verschiedenen Diversity, Equity & Inclusion (DE&I) Arbeitsgruppen wie, u. a. Empowered Women, LGBT*IQ , DisAbility, X-Gen engagieren. 

Joy: Wenn wir unsere Arbeit als sinnstiftend erleben, erhalten wir auch viel zurück. Das erreichen wir, indem wir stolz auf den Beitrag sind, den wir leisten, uns gegenseitig wertschätzen und dies auch mit Freude und Anerkennung teilen. Unser BRAVO Award Programm gibt uns hier eine wertschätzende Möglichkeit dazu. Unsere Mitarbeiter:innen profitieren auch während der Arbeitszeit von einem umfangreichen Betrieblichen Gesundheitsmanagement "Pfizer in Balance".

Wir glauben an Partizipation und binden unsere Mitarbeiter:innen aktiv in unser gesellschaftliches Engagement ein. So schaffen wir ein gemeinsames Werteverständnis und ermöglichen jedem, diese im Arbeitsalltag einzubringen und weiterzutragen. Die Möglichkeit sich sozial zu engagieren, erhalten Sie bei uns u.a. während der Engagement Tage, durch Online Mentoring für Geflüchtete und vieles mehr.

Selbstverständlich sind für uns eine faire Vergütung nach dem Tarifvertrag IG BCE sowie eine ansprechende Altersvorsorge und viele weitere attraktive Benefits. 

Weiterführende Informationen erhalten Sie auf unserer Website unter: Arbeiten bei Pfizer Deutschland 

Bei weiteren Fragen stehe ich Ihnen sehr gerne zur Verfügung.
Luisa Strack I karriere@pfizer.com 

Regulatory Affairs

Job Description

General Summary:

The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition.

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

KEY DUTIES AND RESPONSIBILITIES:                

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Responsible for approval of COAs
• Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of Manufacturing documents.
• Responsible for raw material release, area clearance, line clearance and equipment release.
• May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support of change controls, GMP investigations and CAPAs.
• Participate in compliance walkthroughs and help drive the closure of any audit observations.
• Responsible for identifying risks and communicating gaps for GMP process/systems.
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities.  
• Participate in process improvement initiatives and ongoing Project (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

REQUIRED EDUCATION AND EXPERIENCE:

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network based applications such as Oracle, Veeva
• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.

On-Site Roles

In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #LI-AR1

Company Information

Job Description

General Summary:

The Senior Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Senior Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product manufacturing and disposition.

**In this On-Site designated role, you will work five days per week on-site with ad hoc flexibility.**

KEY DUTIES AND RESPONSABILITIES:

• Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
• Responsible for approval of COAs, generating BSE/TSE statement and product labelling.
• Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
• Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
• Review and approval of Manufacturing documents.
• Responsible for raw material release, area clearance, line clearance and equipment release.
• May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
• Provide QA support of change controls, GMP investigations and CAPAs.
• Participate in compliance walkthroughs and help drive the closure of any audit observations.
• Responsible for identifying risks and communicating gaps for GMP process/systems.
• Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
• Participate in continuous improvements of department processes.
• Participate in inspection readiness and support activities.  
• Participate in process improvement initiatives and ongoing Project (as necessary).
• Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.

REQUIRED EDUCATION AND EXPERIENCE:

• Demonstrated success by independently leading cross-functional teams
• Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
• Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network based applications such as Oracle, Veeva
• Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.            

On-Site Roles

In this 2nd shift, On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #LI-AR1

Company Information

The Role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives. Moderna's commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients' lives worldwide.

Moderna's strategic partnership with the UK Government is exemplified by our innovative presence at Harwell. Our mission is to establish a leading-edge research, development, and manufacturing facility part of a long-term commitment to onshore mRNA vaccine production for respiratory diseases. This initiative will create a multitude of highly skilled jobs and foster collaboration with academic and NHS partners across the UK. We're looking for global experts eager to join us in this endeavor, contributing to a future where access to life-saving vaccines is a reality for all​​.

The Site Compliance Head at Moderna’s Harwell, UK site plays a pivotal role in implementing world-class quality system processes and operations. This leadership position is responsible for ensuring the highest level of compliance, providing strategic direction for the application of Moderna’s Quality Management System (QMS) in support of internal manufacturing of commercially registered products. The role involves assessing and monitoring the health of the QMS for continuous improvement, leading cross-functionally to maintain a state of inspection readiness, and building a culture of quality across the site.

Here’s What You’ll Do

Your key responsibilities will be:

• Implementing Moderna’s overall Quality Management System (QMS), quality manual, policies, and procedures at the site.

• Serving as a cross-functional quality leader and a GXP compliance subject matter expert.

• Overseeing the performance and effectiveness of QMS programs, including Quality Risk Management, Training, Documentation and Records Management, and Data Integrity.

• Maintaining the site in a constant state of inspection readiness, hosting inspections, and engaging directly with Health Authority inspectors.

• Evaluating business goals, identifying improvement opportunities, and applying problem-solving techniques to improve product quality and process effectiveness.

Your responsibilities will also include:

• Leading Management review meetings and monitoring the state of control of Moderna’s QMS at the site.

• Serving as the site compliance representative on Global Compliance Councils.

• Working collaboratively with the Compliance organizations across Global and the sites, along with the digital team, to drive effective and efficient processes supported with digital e-systems.

The key Moderna Mindsets you’ll need to succeed in the role:

• We behave like owners: Taking ownership of the quality and compliance of our Harwell site, ensuring that every action reflects our commitment to excellence.

• We pivot fearlessly: Embracing the dynamic nature of compliance and quality management, ready to adapt and respond to new data or regulations to maintain our high standards.

Here’s What You’ll Bring to the Table:

• Bachelor degree, preferably in Sciences or Engineering

• Applied Quality industry experience of 10+ years.

• Demonstrated experience with Pharmaceutical Quality Systems.

• Inspection experience preferred.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:

• Quality healthcare and insurance benefits
• Lifestyle Spending Accounts to create your own pathway to well-being
• Free premium access to fitness, nutrition, and mindfulness classes
• Family planning and adoption benefits
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
• Educational resources
• Savings and investments
• Location-specific perks and extras!

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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Title:

Visitor Control Center Security Clerk

Position Description

This position provides administrative and customer service support to the Visitor Control Center at the Naval Research Laboratory (NRL) in Washington, DC. The position will have the following responsibilities:

• Serves as security assistant in NRL Visitor Control Center, which also functions as the NRL pass and ID Office. This is a busy and fast-paced environment, where the work is constant, with minimum downtime. Punctuality at the beginning of the work shift is absolutely critical.
• Greets and signs-in visitors to NRL and process visit requests.
• Determines the purpose of visit and assures positive ID before allowing visitor entry onto the Laboratory.
• Process foreign national visitors by verifying identification/immigrant alien status.
• Process unclassified/classified meetings, verifies clearances for employees, contractors and visitors, processes badges for employees/contractors, issues car passes, after citing necessary state registration.
• Collects fingerprints as required for individual clearance processing.
• Processes VIP requests, databases visit requests for contractor.
• Files, classifies and retrieves material in an established filing system.
• Files and updates databases and checks the status of Personnel Security and investigative actions.
• Assists with a variety of administrative matters as directed.
• Must be familiar with use of computer as it relates to updating various Visitor Control related information.

Qualifications

• High School Diploma or GED equivalent and 4 years of related experience in the area of security.
• Must have an active Secret clearance in order to be considered. 

Additional Preferred Qualifications:

• Previous experience with the Defense Biometric Identification System (DBIDS), Real-time Automated Personnel Identification System (RAPIDS), Defense Enrollment Eligibility Reporting System (DEERS), and LiveScan Fingerprinting Systems is highly desired.

KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

The Opportunity

Our location in Sylmar, CA currently has an opportunity on-site for a Quality Systems Analyst I.  This position is responsible for administrative and tactical activities that support the efficient functioning of Quality Assurance and the Quality System.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Participate in Quality System processes which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation.
• Assist in determining quality attributes and requirements. may provide technical assistance.
• Utilize quality management techniques to perform investigations and facilitate solutions.
• Responsible for completing documentation in a timely manner and in accordance with business standards.
• Participate on cross-functional teams.
• Other tasks and duties as assigned.
• Understand and comply with applicable EHS policies, procedures and guidelines.
• Works under the supervision of more experienced staff who review results for overall accuracy, completeness and sound judgment.
• Recognizes risks versus the relative gains associated with actions; understands a project's critical success factors and makes recommendations and decisions impacting those factors.
• Responsible to meet established objectives and goals.
• Drives functional performance to ensure that cross-functional standards and expectations are met.
• May assist in the training of personnel as directed by management.

Required Qualifications  

• Bachelor’s Degree OR an equivalent combination of education or work experience.  
• Entry level position in which 0-2 years of experience is typical to meet the skills and responsibilities of the position.
• Knowledge of FDA Quality System Requirements and other applicable US Code of Federal Regulations for Devices.
• Knowledge of ISO 13485 standard.
• Knowledge of quality management techniques and application.
• Ability to clearly, concisely and accurately convey written and oral communications.
• Ability to form and develop interpersonal, professional relationships.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups as well as work cross-functionally across teams.
• Demonstrated initiative, critical-thinking and problem-solving skills.
• Ability or aptitude to use various types of databases and other computer software.
• Strong organizational skills.
• Ability to prioritize and multitask.
• Ability or aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
• Ability to quickly gain knowledge, understanding or skills and is willing to learn.

Preferred Qualifications 

• Bachelor’s degree.
• Prior medical device experience
• Experience working in a broader enterprise/cross-division business unit model
• Prior audit experience.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

     

The base pay for this position is

$55,200.00 – $110,400.00

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

MD Medical Devices

        

LOCATION:

United States > Sylmar : 15900 Valley View Court

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

     

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

     

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Evotec (US) Inc. is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.