Senior Quality Assurance Specialist

3 weeks 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 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

    3 weeks 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

    4 weeks 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 week ago

    York, United Kingdom Pivot Search Full time

    Job DescriptionSenior 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,...

  • Senior Quality Assurance Specialist

    4 weeks 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

    4 weeks 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

    4 weeks 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

    4 weeks 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

    5 days ago

    York, United Kingdom Eclectic Recruitment Full time

    Our client is a growing, food manufacturing businesses with offices around the globe. They are looking for a Quality Assurance Manager to join them on a full time, permanent basis. **Key duties will include**: - Undertaking audits - Ensuring product standards - Control of products - Ensuring good manufacturing processes - Crisis management - Experience...

  • Construction Assurance Specialist

    4 weeks ago

    York, United Kingdom Network Rail Full time

    Construction Assurance Specialist [PSM-N] **Location**: York, GB **Department Name**: Eastern Region **About Network Rail**: **Vacancy**: Construction Assurance Specialist **Location**: York **Salary**: £43,588 to £49,037 Capital Delivery Eastern has the greatest proportion of enhancement delivery in Control Period 6 (2019-2024) and delivers £3...

  • Associate Director Quality Assurance

    3 weeks ago

    York, United Kingdom Pivot Search Full time

    Associate Director Quality AssuranceSUMMARY: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...

  • Associate Director Quality Assurance

    4 weeks ago

    York, United Kingdom Pivot Search Full time

    Associate Director Quality AssuranceSUMMARY: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...

  • Associate Director Quality Assurance

    3 weeks ago

    York, 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

    4 weeks ago

    York, United Kingdom Pivot Search Full time

    Associate Director Quality AssuranceSUMMARY: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...

  • Associate Director Quality Assurance

    3 weeks ago

    York, United Kingdom Pivot Search Full time

    Associate Director Quality AssuranceSUMMARY: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...

  • Associate Director Quality Assurance

    1 week ago

    York, United Kingdom Pivot Search Full time

    Job DescriptionAssociate Director Quality AssuranceSUMMARY: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...

  • Associate Director of Quality Assurance and

    4 weeks 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...

  • Associate Director of Quality Assurance and

    4 weeks 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...

  • Self Employed Internal Quality Assurers

    4 weeks ago

    York, United Kingdom City of York Council Full time

    SELF EMPLOYED - part time INTERNAL QUALITY ASSURER FOR CHILDCARE, ADULT CARE AND BUSINESS ADMINISTRATION The City of York Council, York Learning Community Education department has exciting opportunities for suitably qualified people. We are looking for appropriately qualified, motivated people to work with us on a part time, self-employed basis to...

  • Associate Director Quality Assurance

    4 weeks 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

    4 weeks 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...