Total 3 Quality Assurance Manager job vacancies in Dundee, Dundee, DD2 1XA

Are you an experienced Quality Control Analyst? Or, are you a recent graduate within a scientific discipline?

We are recruiting for a QC Analyst to carry out the testing of raw materials, process intermediate and finished product testing.

The successful candidate will be joining a global rapid diagnostics testing business based in Dundee, working 37.5 hours per week on a bi-weekly rotating shift pattern across Mon-Fri 06:00-14:00 and 14:00-22:00

This position is offered as a contract opportunity for 5 months initially, with the potential to be extended or turn into a permanent position.

Responsibilities:

• Independent testing of raw material, process intermediate and finished product testing versus predefined acceptance specifications
• Documenting test results in accordance with cGMP/cGDPs
• Using statistical process control of raw material, process intermediates and finished product performance to ensure lot to lot consistency
• Recommend positive interventions/process adjustments to Product Quality Control Supervisor to maintain consistency within predefined limits
• Perform on-market stability and performance testing including participation in analyte proficiency schemes
• Participate in Leader Standard Work within a Management Operating System
• Represent Product Quality Control within audit
• Acts a depute for Product Quality Control Supervisor
• Taking full accountability for personal workload, ensuring work is completed to a high standard in accordance with site policies, procedures and applicable regulations
• Proactively contributing to continuous improvement initiatives and other general housekeeping duties
• Taking a self-motivated approach to continuous professional development and engaging with site training initiatives
• Proposing ideas for new opportunities to improve communication and productivity

Experience & Qualifications:

• Degree or equivalent, preferably a life science subject area, and/or
• Experience in a regulated industry preferred
• Experience within the life sciences or similarly regulated industry (In-vitro Diagnostics preferred)
• A practical understanding of immunoassay and clinical chemistry testing, In-vitro Diagnostics (preferred)
• An ability to employ state-of-the-art Root Cause Analysis (RCA) tools, including A3/DMAIC (preferred)
• The capability to contribute to and perform Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA)
• An understanding of and ability to apply Statistical Process Control (SPC) techniques
• Experience with an Enterprise Resource Planning System (ERP)
• Experience with Electronic Document Management Systems (EDMS)
• Proficient with MS Word, Excel and Power-Point

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

Are you a subject matter expertise in the field of validation, including Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation? If you have a comprehensive understanding of process design and engineering principles, incorporating production processes and controls, including current best practices we would be keen to speak with you!

We are looking for a Process Engineering Manager to join a global rapid diagnostics testing business in Dundee.

You will be responsible for providing leadership and subject matter expertise to support design, installation and qualification of new equipment and processes in accordance with site quality standards.

This position is offered as a contract opportunity, with the potential to turn into a permanent position.

Responsibilities:

• Delivers business-critical capital projects, including process engineering/design/improvement initiatives to drive capacity and productivity improvements
• Develops near-term and long-range plans to identify opportunities for process improvements, new capital equipment and systems, aligning to site strategy for growth with a focus on increasing capacity, improving productivity, reducing costs and protecting the business from equipment/system obsolescence
• Leadership role within in EHS and compliance on-site; delivering safe and compliant equipment, and qualification/validation
• Representing the Operations group in audits (e.g., Quality, Compliance, EHS)
• Balance competing priorities and meet the needs of Operations, Facilities/Engineering, QA, and R&D, ensuring site resources are used effectively, and key site objectives progress within time and budget constraints
• Effective use of all available Key Performance Indicators (KPIs), metrics, and reporting forums to direct focus and attention towards on-time delivery and problem-solving on a daily basis
• Identify opportunities for improvement and areas of risk mitigation to enact strategies which safeguard the business by maintaining state-of-the-art standards in the fields of process, equipment, and systems in accordance with all EHS, Quality, Compliance, and Regulatory requirements.
• Subject matter expertise to the site the fields of process design/improvement, Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation
• Recruits, develops, motivates and disciplines employees to ensure that the Process Engineering group is staffed by individuals of such calibre that can achieve site objectives
• Cultivates Talent Management Reviews and interfaces with the wider Operations Talent Management Review, to ensure employee engagement and development
• Acts as a depute/delegate for Senior Operations Manager

Experience & Qualifications:

• Undergraduate/bachelor's degree in a Life or Biological Science, or Engineering discipline
• Accredited to at least Six Sigma Yellow Belt level
• Background in Operations leadership with excellent communication skills
• Understanding of process design and engineering principles, incorporating production processes and controls, including current best practices
• Subject matter expertise in the field of validation, including Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation
• Demonstrated ability to lead group activities; acting as a facilitator and providing training and upskilling for others
• An understanding of and ability to apply Statistical Process Control (SPC) analyses and techniques with the ability to interpret these analyses and translate to key actionable insights
• The ability to manage and control project budgets
• An appreciation for Enterprise Resource Planning (ERP) processes, including costs and how to influence them
• An understanding of Corrective and Preventative Action (CAPA) and Change Control principles with the ability to process records within the respective databases/systems
• Expertise in and ability to support/facilitate use of state-of-the-art Root Cause Analysis (RCA) tools, including 5-Whys, A3/DMAIC, AID interviews
• Understanding of risk analysis principles, and capability to lead and support Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA)

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.

Are you a subject matter expertise in the field of validation, including Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation? If you have a comprehensive understanding of process design and engineering principles, incorporating production processes and controls, including current best practices we would be keen to speak with you!

We are looking for a Process Engineering Manager to join a global rapid diagnostics testing business in Dundee.

You will be responsible for providing leadership and subject matter expertise to support design, installation and qualification of new equipment and processes in accordance with site quality standards.

This position is offered as a contract opportunity, with the potential to turn into a permanent position.

Responsibilities:

• Delivers business-critical capital projects, including process engineering/design/improvement initiatives to drive capacity and productivity improvements
• Develops near-term and long-range plans to identify opportunities for process improvements, new capital equipment and systems, aligning to site strategy for growth with a focus on increasing capacity, improving productivity, reducing costs and protecting the business from equipment/system obsolescence
• Leadership role within in EHS and compliance on-site; delivering safe and compliant equipment, and qualification/validation
• Representing the Operations group in audits (e.g., Quality, Compliance, EHS)
• Balance competing priorities and meet the needs of Operations, Facilities/Engineering, QA, and R&D, ensuring site resources are used effectively, and key site objectives progress within time and budget constraints
• Effective use of all available Key Performance Indicators (KPIs), metrics, and reporting forums to direct focus and attention towards on-time delivery and problem-solving on a daily basis
• Identify opportunities for improvement and areas of risk mitigation to enact strategies which safeguard the business by maintaining state-of-the-art standards in the fields of process, equipment, and systems in accordance with all EHS, Quality, Compliance, and Regulatory requirements.
• Subject matter expertise to the site the fields of process design/improvement, Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation
• Recruits, develops, motivates and disciplines employees to ensure that the Process Engineering group is staffed by individuals of such calibre that can achieve site objectives
• Cultivates Talent Management Reviews and interfaces with the wider Operations Talent Management Review, to ensure employee engagement and development
• Acts as a depute/delegate for Senior Operations Manager

Experience & Qualifications:

• Undergraduate/bachelor's degree in a Life or Biological Science, or Engineering discipline
• Accredited to at least Six Sigma Yellow Belt level
• Background in Operations leadership with excellent communication skills
• Understanding of process design and engineering principles, incorporating production processes and controls, including current best practices
• Subject matter expertise in the field of validation, including Process Validation, Equipment Validation, Test Method Validation, and Non-Product Software Validation
• Demonstrated ability to lead group activities; acting as a facilitator and providing training and upskilling for others
• An understanding of and ability to apply Statistical Process Control (SPC) analyses and techniques with the ability to interpret these analyses and translate to key actionable insights
• The ability to manage and control project budgets
• An appreciation for Enterprise Resource Planning (ERP) processes, including costs and how to influence them
• An understanding of Corrective and Preventative Action (CAPA) and Change Control principles with the ability to process records within the respective databases/systems
• Expertise in and ability to support/facilitate use of state-of-the-art Root Cause Analysis (RCA) tools, including 5-Whys, A3/DMAIC, AID interviews
• Understanding of risk analysis principles, and capability to lead and support Risk Assessments, Risk Management/Control exercises, and Failure Mode Effect Analyses (FMEA)

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.