QC Scientist

GSK; King of Prussia (PA); On-site; USD 75,000 - 110,000; Full time

Job summary

GSK is seeking a QC Scientist – Microbiology in King of Prussia, PA. This laboratory role focuses on Bioburden and Bacterial Endotoxin Testing (BET) in a GMP-regulated environment, with 80% hands‑on testing and 20% lab support.

Open availability is required, including some weekend work, and the role collaborates across Quality, Manufacturing and Technical Operations. The position emphasizes data integrity, method transfers and batch release support.

Qualifications

• Bachelor’s degree with 3+ years microbiology lab experience OR equivalent combinations.
• Experience in GMP/GxP regulated environment.
• Experience performing Bioburden and BET.

Responsibilities

• Perform routine and non-routine microbiological testing of materials and products.
• Execute Bioburden and Bacterial Endotoxin Testing per procedures.
• Support product release, stability studies, validations, and manufacturing ops.
• Collect and test utility samples from water, steam and gas systems.
• Escalate quality or compliance concerns to management.
• Document activities and results in compliance with data integrity principles.
• Identify opportunities for process improvements and efficiencies.
• Assist with housekeeping, inventory, and lab support duties.
• Support method qualifications, transfers, and equipment qualifications.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelors in Microbiology/Biology/Biotechnology

Associate degree in Life Science

Master's in Microbiology/Biology

Tools

SAP/ERP

LES/LES-EM

LIMS

WebStatistica

ELN systems

Veeva

Job description

The QC Scientist – Microbiology is responsible for performing and supporting microbiological testing activities for raw materials, in-process materials, drug substance, drug products, utilities, and environmental monitoring samples in a GMP-regulated pharmaceutical manufacturing environment. This laboratory-based position consists of approximately 80% hands-on testing and 20% laboratory support activities, with a primary focus on Bioburden and Bacterial Endotoxin Testing (BET).

This position requires open availability with the understanding that some weekend work will be required, additionally this role requires the ability to work independently while effectively collaborating across Quality, Manufacturing, and Technical Operations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

Why you?

• Perform routine and non-routine microbiological testing of: Raw materials, In-process samples, Drug substance, Drug product, EM/UM samples
• Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) in accordance with approved procedures and compendial requirements.
• Perform testing to support product release, stability studies, validation activities, and manufacturing operations.
• Collect, test, review, and trend utility monitoring samples from pharmaceutical water systems, clean steam, and compressed gas systems.
• Escalate quality or compliance concerns promptly to management.
• Accurately document laboratory activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
• Identify opportunities for process improvements and laboratory efficiencies.
• Perform routine laboratory housekeeping and inventory management activities.
• Support method qualifications, method transfers, equipment qualifications, and validation activities as assigned.
• Performs other duties as assigned.

Basic Qualifications:

• Bachelor’s degree in microbiology, Biology, Biotechnology, or a related Life Science discipline with 3+ years of hands-on microbiology laboratory experience
• OR associate degree in a scientific discipline with 5+ years of hands-on microbiology laboratory experience
• OR master’s degree in microbiology, Biology, or a related Life Science discipline with a minimum of 1 year of hands-on microbiology experience in a GMP-regulated environment.
• Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, medical device, or healthcare environment.
• Experience performing Bioburden and Bacterial Endotoxin Testing (BET).

Preferred Qualifications:

• 3+ years of previous experience working in a GMP QC Microbiology Laboratory
• Advanced experience with testing microbiological compendial methods in line with: USP, EP, and JP requirements, ICH guidelines and FDA expectations.
• SAP or ERP, LES/LES-EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, Veeva.
• Experience supporting investigations, CAPAs, deviations, and change controls.

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?

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.

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.

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