Analytical Quality & Compliance Specialist will focus on Quality Assurance (QA) review and approval of technical documents pertaining to GMP analytical methods for biologics drug substances and drug products. The scope of documents will range from early clinical development through registration and commercial lifecycle. Specific technical document types include analytical method procedures, method validation protocols and reports, method transfer protocols and reports, reference standard and critical reagent qualification protocols and reports, certificates of analysis, 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 resolutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical transfer 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 8 years professional experience in Biologics Quality Assurance, Quality Control, analytical method development and/or validation areas
- Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, TrackWise) is desirable.