Senior Quality Assurance Specialist - Validation
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.
Job Summary
Provides oversight of SDC’s quality management system (QMS) and notifies management of issues. Actively participates in collecting and reporting quality metric data and provides related input to leadership as required. Conducts detailed inquiries into quality related issues to propose appropriate corrective actions and lessons learned. Analyzes quality KPIs (Key Performance Indicators) for trends and improvement opportunities. Serves as the senior quality lead on internal validation projects and manages the supplier qualification program, performing audits as needed. Mentors quality and other SDC personnel as needed.
Primary Responsibilities
• Serves as the QA lead on validation projects, which includes providing validation guidance to teams as well as reviewing and approving all validation documentation (Validation Plans, Specifications, Executed Scripts, Validation Summary Reports, Change Controls).
• Manages the supplier qualification program; ensures compliance with current process, and suggests improvements to the program as needed.
• Conducts internal and external (supplier) audits as needed.
• Assists with data collection, trending, and reporting of Quality KPI metrics.
• Identifies areas of quality deficiency ensuring escalation to leadership and communication with appropriate staff.
• Acts as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as required.
• Creates and revises documentation as needed (SOPs, Policies, Work Instructions).
• Mentors quality and SDC personnel as needed.
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements.
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Skills
• Thorough understanding and application of validation and software development lifecycle, including Good Automated Manufacturing Practice (GAMP) guideline.
• Ability to work independently on various projects while also mentoring staff.
• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
• Thorough knowledge, understanding, and application of ICH Guidelines for Good Clinical Practice, Annex 11, and Title 21 of the Code of Federal Regulations, including 21CFRPart11.
• Good analytical skills with the ability to evaluate data trends for lessons learned, required action, etc.
• Excellent verbal and written communication skills
• Excellent collaboration skills
• Ability to multitask in a very fast paced environment with multiple priorities
Education or Equivalent Experience
• Typically a Bachelor’s degree in applied or life science or engineering with advanced degree preferred or equivalent education and experience.
• Typically 5+ years of experience is preferred in Quality within the pharmaceutical/CRO industry or equivalent combination of experience, education and/or demonstrated ability.
• Previous experience managing and performing audits is required.
Why SDC
• We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits.
• We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment.
• We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
• We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry.
• With a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
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