Supv, Quality Lab

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Here, you will find more than just a job—you will find purpose and pride.

Summary:

Provides leadership and technical oversight for the QC Microbiology Laboratory supporting aseptic manufacturing operations. Responsible for supervising environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing activities while ensuring compliance with cGMP, FDA, USP, and regulatory requirements. Leads investigation activities, supports regulatory inspections and customer audits, and ensures laboratory operations maintain a state of inspection readiness.

Essential Duties and Responsibilities:

• Provide microbiological oversight and support for aseptic manufacturing operations, including environmental monitoring programs, contamination control initiatives, and process monitoring activities.
• Provide clear communication regarding goals, expectations, and daily priorities; collaborate with other supervisors and management to ensure alignment and escalate risks.
• Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective counseling in a timely manner.
• Ensure compliance with ALCOA+ principles, data integrity requirements, electronic records requirements, and applicable laboratory procedures.
• Ensure timely completion and review of environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing in support of manufacturing operations and product release.
• Ensure laboratory personnel recognize, contain, document, and escalate quality related deviations or nonconformances in a timely manner.
• Lead and approve microbiological investigations involving environmental monitoring excursions, sterility failures, bioburden excursions, endotoxin results, contamination events, laboratory deviations, and out of specification events while ensuring scientifically sound product impact and risk assessments. Utilize structured root cause analysis tools and Quality Risk Management principles to identify causes and implement effective CAPAs.
• Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, and USP rules and guidelines) and ensure compliance with standard operating procedures and specifications.
• Act as a primary laboratory representative during FDA, MOH, corporate, customer, and third-party audits. Support audit preparation, inspection readiness activities, response development, and implementation of corrective actions.
• Review and trend microbiological data to identify emerging risks, process shifts, adverse trends, and opportunities for continuous improvement. Communicate microbiological risks and recommendations to site leadership.
• Prepare, review, and revise standard operating procedure and specifications.
• Ensure equipment maintenance and calibration are performed on schedule.
• Ensure laboratory operations remain inspection ready through adherence to procedures, completion of training, timely closure of quality records, and maintenance of laboratory documentation.

Qualifications:

• Must not be allergic to Penicillin and Cephalosporin or their related product and/or materials.
• Must possess excellent supervisory and interpersonal skills and be able to communicate with subordinates, peers and managers.
• Strong knowledge of USP <71>, USP <85>, USP <61>/<62>, USP <1116>, Annex 1, and aseptic processing regulatory expectations.
• Demonstrated knowledge of current FDA Guidance for Sterile Drug Products Produced by Aseptic Processing and applicable global regulatory requirements.
• Experience supporting FDA and regulatory inspections.
• Knowledge of contamination control principles, aseptic behavior monitoring, environmental monitoring programs, and sterility assurance systems.
• Demonstrated experience with microbiological risk assessments and quality systems investigations.
• Proficiency in electronic quality management systems, LIMS, and data trending tools.
• Ability to evaluate microbiological risks and effectively communicate findings to cross-functional stakeholders.
• Ability to lift up to 50 pounds when required.
• Occasional off-shift and holiday work required.

Education and/or Experience:

• Bachelor's degree in Microbiology, Biology, or related life science discipline.

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