Quality Control Investigations Specialist

Our San Francisco Bay Area Biotechnology client is recruiting for a Quality Control Investigations Specialist for a 6 month-contract (hybrid schedule 3-4 days onsite 9am-5pm). You will execute and manage laboratory investigations in the quality management system and work cross-collaboratively with supervisors, leads and QC analysts to conduct investigations and identify root cause(s) for laboratory investigations, deviations & calibration events, environmental monitoring alert, action, adverse trend investigations.

You will have working knowledge of root cause analysis (RCA) methodology and testing methods (e.g Bioburden, Endotoxin, A280, HPLC/UPLC, PCR, ELISA, Bradford, Activity and Bioassays) to support QC investigations involving multiple manufacturing modalities (e.g. Gene Therapy, Biologics, Small Molecules). The scope covers both clinical programs and commercial products.

Responsibilities:

• Aligning internal review team and area subject matter experts on an agreed investigational path forward.
• Technical writing of investigations, translating very complex and challenging scientific events into a concise, accurate and cohesive report.
• Assign child records to appropriate groups and provide guidance on investigations to operational staff.
• Identify proper CAPA after investigation process is complete plus, if applicable, sequential Effectiveness Check strategy, and provide ownership whenever necessary.
• Work with QC team for data gathering, observing processes for investigations, and performance of associate interview.
• Lead deviation investigations related to QC laboratory, excursions, and adverse trends.
• Work with management and quality assurance in on-time closures of Deviations and LIRs.
• Identify trends and work with the appropriate teams on resolution.
• Lead laboratory investigations for OOS, OOE, OOTs and system suitability failures.
• Help develop and improve policies, procedures, and business practices to maintain and/or enhance compliance status.
• Ensure that Quality Control investigations are in a state of compliance with all company standards and current industry and regulatory standards.
• Build cross-functional workgroups and facilitate identification of the true root cause utilizing root cause analysis tools (fishbone, 5 Why's, etc.).

Requirements:

• Bachelor's degree in biological sciences or biochemical sciences
• 4+ years of QC experience in the pharmaceutical laboratory industry
• Knowledge of quality management systems, current Good Manufacturing Practices, expertise with QC principles and compliance requirements.

Pay Scale:

• $40.27 to $50.34 per hour

R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer.