Senior Quality Assurance Specialist

4 weeks ago

York, United Kingdom Pivot Search Full time
Job Description

Senior Quality Assurance Specialist


The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and continuously improving the site's Audit program. Interfacing with business and functional leaders in regulated operational areas, they actively promote and support compliance. Furthermore, the Senior Quality Assurance Specialist contributes significantly to the generation of Key Quality Performance Indicators for my client's Quality Systems.


Qualifications


  • Bachelor’s degree (preferred)
  • 3+ years of experience in a laboratory, pharmaceutical, medical device, or clinical research organization (required)
  • Demonstrated experience in GCP, ISO15189, NEQAS, CAP, CLIA (strongly preferred)
  • Certified Quality Auditor (preferred)


RESPONSIBILITIES


Quality Assurance Responsibilities:

  • Ensure the efficiency of the Quality System/personnel for the business, emphasizing compliance in areas such as Quality Issues, Change Controls, and CAPAs.
  • Lead the development and execution of Quality Improvement projects.
  • Develop, implement, and maintain auditing strategies to ensure ongoing compliance with current regulations and guidelines.
  • Independently monitor all study types conducted within BioA, as required by regulations and SOP.
  • Conduct various types of Quality Assurance audits, including process, facility, SOP, CSV, and study audits.
  • Review and maintain the BioA Central Events log, ensuring timely completion of proposed corrective and preventative actions (CAPA) by management.
  • Act as Deputy Archivist, responsible for maintaining the archive and its contents in compliance with relevant regulations.
  • Introduce systems to comply with revised GLP, GCP, EMA, FDA, and OECD guidelines or regulations.
  • Provide support/host customer-initiated audits, mock regulatory inspections, and regulatory facility inspections.
  • Participate in the review of root cause analysis, corrective action, and preventive action plans for internal, 3rd party, and vendor audits.


Process Improvement Responsibilities:

  • Lead the development, improvement, implementation, and maintenance of new/modified quality systems to ensure GLP and GCP compliance.
  • Recommend systems for audit, write audit plans, and coordinate scheduling and closure of internal audits.


Training and Mentoring:

  • Provide training and mentoring to Quality Assurance personnel within BioA, fostering professional development and ensuring adherence to quality standards.

  • Senior Quality Assurance Specialist

    2 months ago

    York, United Kingdom Pivot Search Full time

    Senior Quality Assurance SpecialistThe Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Senior Quality Assurance Specialist

    1 month ago

    York, United Kingdom Pivot Search Full time

    Senior Quality Assurance SpecialistThe Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Senior Quality Assurance Specialist

    2 months ago

    York, United Kingdom Pivot Search Full time

    Senior Quality Assurance SpecialistThe Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Senior Quality Assurance Specialist

    1 month ago

    York, United Kingdom Pivot Search Full time

    Senior Quality Assurance Specialist The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Senior Quality Assurance Specialist

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Senior Quality Assurance Specialist The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Senior Quality Assurance Specialist

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Senior Quality Assurance Specialist The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Quality Assurance Specialist

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Senior Quality Assurance Specialist The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Quality Assurance Specialist

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Senior Quality Assurance Specialist The Senior Quality Assurance Specialist plays a pivotal role in fostering a culture of audit readiness within the Quality team. Responsible for overseeing Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) activities within the BioA department, this specialist is dedicated to developing, implementing, and...

  • Quality Assurance Officer

    3 days ago

    York, United Kingdom The Disabilities Trust Full time

    **Quality Assurance Officer** **York - Hybrid Working** **Salary: Up to £29,000 per annum** **Hours: 35 Hours per week** **Why join us?** **Brainkind is a charity that aims to improve the lives of people** **with brain injuries in the UK.** Our assessment centres, rehabilitation units and hospitals use expert neurorehabilitation to support people to...

  • Quality Assurance Officer

    1 week ago

    York, United Kingdom Brainkind Full time

    Quality Assurance OfficerThe following information aims to provide potential candidates with a better understanding of the requirements for this role.York – Hybrid WorkingSalary: Up to £29,000 per annumHours: 35 Hours per weekWhy join us?Brainkind is a charity that aims to improve the lives of people with brain injuries in the UK. Our assessment centres,...

  • Quality Assurance Officer

    7 days ago

    York, United Kingdom Brainkind Full time

    Quality Assurance OfficerThe following information aims to provide potential candidates with a better understanding of the requirements for this role.York – Hybrid WorkingSalary: Up to £29,000 per annumHours: 35 Hours per weekWhy join us?Brainkind is a charity that aims to improve the lives of people with brain injuries in the UK. Our assessment centres,...

  • Quality Assurance Officer

    2 days ago

    York, United Kingdom Nudge Minds Full time

    **Can you help us on our mission to ensure every child can live a Life Worth Living?** **Who we are**: We are Nudge Education. Last year in the UK around 90,000 young people were persistently absent from education. This needs to change. We exist to ensure that children who are chronically disengaged from education are never left behind and can receive life...

  • Head of Quality Assurance

    4 weeks ago

    York, United Kingdom Department for Environment, Food and Rural Affairs (Defra) Full time

    **Job description** The Head of Quality Assurance (QA) and Test is the most senior role within the DDTS Digital function and leads the QA & Test profession. You will set Defra’s technical test strategy and lead the direction of the software quality assurance for Defra. Accountable for multiple teams and services that provide software quality assurance...

  • Claims Quality Assurance Analyst

    1 month ago

    York, United Kingdom Claims Recruitment Services Full time

    **Claims Quality Assurance Analyst** **York** **Negotiable Salary + Excellent Benefits** We are currently recruiting for a Claims Quality Assurance Analyst on behalf of our client, one of the leading brands in the UK insurance market. **Key Responsibilities** - Supporting management with overseeing the completion of the monthly peer review programme and...

  • Associate Director, Quality Assurance

    7 days ago

    York, United Kingdom ACM Global Laboratories, Inc. Full time

    Associate Director, Quality Assurance page is loaded Associate Director, Quality Assurance Apply locations ACM - York Building 23 time type Full time posted on Posted 3 Days Ago job requisition id REQ_195463 HOW WE CARE FOR YOU: At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster...

  • Quality Assurance Officer

    1 day ago

    York, North Yorkshire, United Kingdom Brainkind Full time €29,000

    Quality Assurance Officer The following information aims to provide potential candidates with a better understanding of the requirements for this role. York – Hybrid Working Salary: Up to £29,000 per annum Hours: 35 Hours per week Why join us? Brainkind is a charity that aims to improve the lives of people with brain injuries in the UK. Our...

  • Associate Director of Quality Assurance and

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Associate Director Quality Assurance The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical Trials...

  • Quality Assurance Officer

    1 day ago

    York, North Yorkshire, United Kingdom Brainkind Full time €29,000

    Quality Assurance Officer York - Hybrid Working Our assessment centres, rehabilitation units and hospitals use expert neurorehabilitation to support people to regain the skills they have lost. To support delivery of the Quality Assurance Team strategy by providing specialist support with production of compliance reports, themed analysis, and management...

  • Associate Director Quality Assurance

    2 months ago

    York, North Yorkshire, United Kingdom Pivot Search Full time

    Associate Director Quality Assurance SUMMARY: The Associate Director, Quality Assurance is tasked with implementing strategies to ensure successful delivery of high-quality Clinical Trials studies. This involves driving effective and efficient global processes within the realm of Quality and Operations. This leader collaborates closely with the Clinical...

  • Associate Director, Quality Assurance

    7 days ago

    York, North Yorkshire, United Kingdom ACM Global Laboratories, Inc. Full time €10

    Associate Director, Quality Assurance page is loaded Associate Director, Quality Assurance Apply locations ACM - York Building 23 time type Full time posted on Posted 3 Days Ago job requisition id REQ_195463 HOW WE CARE FOR YOU: At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster...