Associate/ Sr. Associate, Quality Control
The Associate/ Sr. Associate, Quality Control will participate in performing multi-facility routine and investigational environmental monitoring (EM) of the GMP manufacturing suites. They are also responsible for performing microbiological analysis of raw materials, finished products, and other samples as required. Establish a microbiology lab to include the in-sourcing of microbiological testing.
- Performs activities in support of environmental monitoring including surface, viable air, non-viable air, and personnel monitoring.
- Performs activities in support of bioburden testing of water, clean rinse samples and product, conductivity, TOC, and chemical testing of compressed gases.
- Perform investigations for out of specification or limits occurrences and deviations.
- Determine preventative and corrective actions for laboratory investigations.
- Outsource ID testing of recovered microorganisms. Interpret microorganism ID results to determine impact on facility.
- Qualify lots of reagents and test materials to be used for EM and microbiological testing.
- Performs activities in support of final product release testing (e.g. tests applicable for endotoxin, sterility, and toxicity) and raw material testing (e.g. microbial limits, endotoxin, and potency) where required.
- Develop and execute microbiological methods such as Microbial Enumeration, Sterility, Endotoxin, Antimicrobial Effectiveness, Container Closure Integrity and non-routine microbiological assays.
- Provide technical oversight of microbiological compendial and non-compendial testing.
- Performing peer and technical review of laboratory data.
- Writing/reviewing of microbiological test methods and SOP’s.
- Evaluate trend data and author trend reports to proactively identify adverse trends.
- Keep accurate and complete records per cGMP.
- Perform other duties as assigned.
- BS in Microbiology or a Life Sciences related discipline.
- Minimum of seven (7) years’ experience in the pharmaceutical industry, to include: environmental monitoring experience and experience with microbiological testing such as bioburden, microbial identification, gram staining, water testing as per USP (membrane filtration, conductivity, and TOC), and growth promotion assay.
- Experiencing working in varying ISO grade clean rooms.
- Working knowledge of microbiological compendial assays (USP <61> and USP <62>).
- Experience writing quarterly/ annual reports for EM and water trending.
- Knowledge of cGMP and ICH.
- Possess a strong work ethic along with a solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills.
- Demonstrated experience working independently, quickly, and be flexible with scheduling.
- Demonstrated experience analyzing critical data and proactively solving problems.
- Experience performing growth promotion testing, cell culturing, and gram staining.
- Experience insourcing and validation of microbiological assays.
- Experience authoring trend reports using statistical tools (e.g. CuSum).