Senior QA Officer

Senior QA Officer focuses on leading activities that support the cgt manufacturing and weighing schedules.

What the role involves

• Leading activities that support the CGT manufacturing and weighing schedules.
• Leading the review, approval and release of Batch Production Records and Quality Control testing data.
• Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.
• Change Control: Lead Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly.
• Experienced internal auditor for ISO 9001, ISO13485 or cGMP.
• Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actio.

Skills and requirements

• BSc/BA degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.
• Experience of maintaining Quality Management Systems to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.
• Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated products.

Confirmed role details

• Lead internal quality related training sessions for the business.
• Experienced in the critical review of CAPA.
• Coach and mentor team members on quality assurance and business requirements including best practices.
• Support a culture of high performance, creativity, teamwork and Bio-Techne’s EPIC values.

Candidate fit

• Ability to critically review documentation.