**Hybrid Role in Novato, CA**
Job opportunity with a top biopharmaceutical company that is looking for a QC Investigations Specialist to join their team on a 6-month contract with an opportunity for conversion or extension!
Qualifications:
- B.S. degree, or equivalent, in a biological or biochemical science
- 4 years of experience in a pharmaceutical laboratory
- 2 years as part of a QC organization.
Job Description/Skills:
- Lead laboratory investigations (LIRs) for OOS, OOE, OOTs and system suitability failures
- Lead deviation investigations related to QC laboratory, excursions, and adverse trends.
- Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.
- Build cross-functional workgroups and facilitate identification of the true root cause utilizing root cause analysis tools (fishbone, 5 Why's, etc.).
- Assign child records to appropriate groups and provide guidance on investigations to operational staff.
- Aligning internal review team and area subject matter experts on an agreed investigational path forward.
- Identify proper CAPA after investigation process is complete plus, if applicable, sequential Effectiveness Check strategy, and provide ownership whenever necessary.
- Identify trends and work with the appropriate teams on resolution.
- Technical writing of investigations, translating very complex and challenging scientific events into a concise, accurate and cohesive report.
- Work with management and quality assurance in on-time closures of Deviations and LIRs.
- Help develop and improve policies, procedures, and business practices to maintain and/or enhance compliance status.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
