Quality Control Microbiology Specialist

Regulatory Toolkit; King of Prussia (PA); On-site; USD 85,000 - 110,000; Full time

Job summary

GSK in King of Prussia, PA is seeking a Quality Control Microbiology Specialist to support QC laboratory operations. You will write, update, and review procedures, lead investigations and CAPAs, and ensure compliant, efficient laboratory performance in a GMP environment.

This role involves data review, troubleshooting, and participation in audit readiness, with collaboration across QA, Manufacturing, Engineering, and MSAT. On-site with limited remote flexibility.

Job description

Job Title: Quality Control Microbiology Specialist

Job Purpose:

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

Key Responsibilities:

• Writes, updates, reviews, and maintains Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current Good Manufacturing Practice (GMP), regulatory, and site requirements.
• Serves as lead investigator for (Quality Control) QC-related Deviations, Laboratory Investigation Reports, Change Controls, and Corrective/Preventive Actions, ensuring timely, scientifically sound, and compliant record closure.
• Provides technical and quality support for laboratory operations, including data review, documentation practices, assay/process troubleshooting, and inspection readiness activities.
• Supports initiatives to improve Quality Operations, laboratory efficiency, schedule adherence, right-first-time performance, and overall GMP performance.
• Leads continuous improvement and problem-solving activities for the QC team using appropriate tools to identify root causes, reduce waste, improve process robustness, and sustain improvements.
• Represents the QC team on site-based projects and cross-functional activities, including maintenance, shutdowns, non-routine work, laboratory readiness, and implementation planning.
• Partners with quality assurance (QA), Manufacturing, Engineering, Validation, MSAT, Supply Chain, and other stakeholders to assess quality impact, resolve issues, and implement sustainable actions.
• Supports internal and external audit/inspection readiness by preparing documentation, providing SME input, responding to requests, and supporting execution of commitments.
• Provides guidance, coaching, and training to laboratory staff on procedures, documentation expectations, investigations, quality systems, and continuous improvement practices.
• Maintains awareness of applicable GMP, regulatory, safety, and site requirements and ensures assigned activities are performed in a compliant and safe manner.

Basic Qualifications:

• Bachelor’s Degree in Biochemistry, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related technical discipline or related experience
• 3+ years of experience in a Good Manufacturing Practice/ Good Practice (GMP/GxP) regulated laboratory, quality, manufacturing, or technical operations environment; experience with laboratory investigations, controlled documents, quality systems, and continuous improvement is preferred.

Preferred Qualifications:

• Master’s Degree Scientific, technical, quality, or laboratory-related discipline
• Demonstrated leadership, ownership, and accountability for quality, technical, and operational deliverables.
• Strong written and verbal communication skills, including the ability to produce clear, compliant, audit-ready documentation.
• Effective problem-solving skills and ability to lead root cause analysis, Corrective and Preventive Action (CAPA) development, and continuous improvement activities.
• Able to prioritize, manage timelines, make risk-based decisions, and implement actions in a complex, fast-paced environment.
• Able to influence without authority and collaborate effectively across QC, QA, Manufacturing, Engineering, Validation, Manufacturing Science and Technology (MSAT), Supply Chain, and site support functions.
• Solid team player able to work independently while supporting team-based laboratory operations and site priorities.
• Knowledge of GMP, International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and other applicable regulatory expectations for laboratory operations, analytical documentation, investigations, and quality systems.
• The incumbent is responsible for adhering to all applicable safety, quality, data integrity, and documentation requirements.

Work Arrangements: 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.

#LI-GSK

Skills

Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail]

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.