Quality Control Microbiology Specialist

GSK; Upper Merion Township (Montgomery County); On-site; USD 85,000 - 110,000; Full time

Job summary

GSK in the United States seeks a Quality Control Microbiology Specialist to support QC laboratory operations, lead investigations, maintain controlled documents, and drive CAPA and continuous improvement within GMP environments.

The role emphasizes collaboration with QA, Manufacturing, Engineering, and MSAT teams, data integrity, and audit readiness, with on-site work as the norm. A Bachelor’s degree and 3+ years GMP/GxP exp are expected.

Qualifications

• Bachelor’s degree in a relevant field and 3+ years of GMP/GxP regulated lab experience.

Responsibilities

• Writes, updates, reviews, and maintains SOPs, methods, specifications and related documents per GMP.
• Leads investigations for Deviations, Laboratory Investigation Reports, Change Controls, and CAPAs.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelor’s Degree in Biochemistry, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related technical discipline

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.

Skills

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

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Unifying 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.

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.

Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.