Quality Control Microbiology Specialist

GSK • King of Prussia, PA

1d • Hybrid

About The Position

The Quality Control Microbiology Specialist supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance. The role writes, updates, and reviews laboratory procedures and technical documents; leads quality investigations and corrective and preventive actions; supports Quality Operations and GMP performance initiatives; drives continuous improvement and problem-solving; and represents the QC team on site-based projects, shutdowns, maintenance activities, and other non-routine work.

The position partners with Quality Assurance, Manufacturing, Engineering, Validation, MSAT, Supply Chain, and other stakeholders to assess quality impacts, resolve issues, and implement sustainable actions. It also provides guidance and training to laboratory staff and supports audit and inspection readiness. This is a predominantly on-site role; limited remote work flexibility may be available, typically up to 1–2 days per week, subject to business needs and manager.

Requirements

• Bachelor’s degree in Biochemistry, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or a related technical discipline, or related experience.
• At least 3 years of experience in a GMP/GxP-regulated laboratory, quality, manufacturing, or technical operations environment.
• Strong written and verbal communication skills, including the ability to produce clear, compliant, audit-ready documentation.
• Problem-solving skills and ability to lead root cause analysis, CAPA development, and continuous improvement activities.
• Ability to prioritize, manage timelines, make risk-based decisions, and implement actions in a complex, fast-paced environment.
• Ability to influence without authority and collaborate across QC, QA, Manufacturing, Engineering, Validation, MSAT, Supply Chain, and site support functions.
• Ability to work independently and as part of a team supporting laboratory operations and site priorities.
• Knowledge of GMP, ICH, FDA, and other applicable regulatory expectations for laboratory operations, analytical documentation, investigations, and quality systems.
• Adherence to applicable safety, quality, data integrity, and documentation requirements.

Nice To Haves

• Experience with laboratory investigations, controlled documents, quality systems, and continuous improvement.
• Master’s degree in a scientific, technical, quality, or laboratory-related discipline.
• Demonstrated leadership, ownership, and accountability for quality, technical, and operational deliverables.

Responsibilities

• Write, update, review, and maintain Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current GMP, regulatory, and site requirements.
• Lead investigations for QC-related Deviations, Laboratory Investigation Reports, Change Controls, and Corrective/Preventive Actions, ensuring timely, scientifically sound, and compliant closure.
• Provide technical and quality support for laboratory operations, including data review, documentation practices, assay and process troubleshooting, and inspection readiness.
• Support initiatives to improve Quality Operations, laboratory efficiency, schedule adherence, right-first-time performance, and overall GMP performance.
• Lead continuous improvement and problem-solving activities using appropriate tools to identify root causes, reduce waste, improve process robustness, and sustain improvements.
• Represent the QC team on site-based projects and cross-functional activities, including maintenance, shutdowns, non-routine work, laboratory readiness, and implementation planning.
• Partner with QA, Manufacturing, Engineering, Validation, MSAT, Supply Chain, and other stakeholders to assess quality impact, resolve issues, and implement sustainable actions.
• Support internal and external audit and inspection readiness by preparing documentation, providing subject-matter-expert input, responding to requests, and supporting execution of commitments.
• Provide guidance, coaching, and training to laboratory staff on procedures, documentation expectations, investigations, quality systems, and continuous improvement practices.
• Maintain awareness of applicable GMP, regulatory, safety, and site requirements and perform assigned activities compliantly and safely.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level