We are recruiting, on behalf of our client, an experienced quality compliance Specialist with expertise in biological analytics. This position is a long term temporary contract.
Main purpose of the role:
The AQ&C Specialist will focus on Quality Assurace (QA) review and approval of technical documents pertaining to GMP analytical methods for small molecules drug substances and drug products. The scope of documents will range from early clinical development through registration and commerical lifecycle of methods. Specific technical document types include analytical method prodedures, method validation protocols and reports, method transfer protcools and reports, reference standard and critical reagent qualifiation protocols and reports, certificates of analysis, analytical change controls and general procedural documents. This QA role will also partner with analytical functional areas to resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.
· Perform the QA review/approval of technical documentation, including but not limited to:
- Analytical method validation protocols and reports for in process, release, and stability testing
- Analytical method procedures and associated change controls
- Method technical transfer protocols and reports
- Reference material and critical reagents qualification protocols and reports
- Standard Operation Procedures and other controlled documents
· Collaborate with clinical or commercial analytical functions to determine the appropriate resoutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical tansfer of analytical methods or qualification of reference material and critical reagents
- Communicate, share and escalate issues within team for consensus resolution
· Assist in the development of procedural and other guidance documents for Quality and QC functions
• Minimum of 5 years professional experience in Biologics Quality Assurance, Quality Control, analytical chemistry, method development is desirable
• Previous experience in QC laboratory facing QA activities is highly desirable
• Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable.
• Experience and/or knowledge of QC biologics testing.
Working knowledge of GMP environment is desirable
• Working knoweldge of QC, QA, analytical method development or method validation functions
• Understanding and knowledge of FDA guidelines and GxP regulations.
• Excellent communication, attention to details, relationship management, negotiation, problem-solving