Job Description
Senior Quality Assurance Specialist
Please make an application promptly if you are a good match for this role due to high levels of interest.
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.