QC Scientist

GSK plc; King of Prussia (PA); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

GSK plc in King of Prussia, PA is seeking a QC Scientist – Microbiology to perform and support microbiological testing of raw materials, in-process materials, drug substances, and products in a GMP manufacturing environment. The role is 80% hands‑on testing and 20% laboratory support, with primary focus on Bioburden and BET.

You will work independently and with Quality, Manufacturing, and Technical Operations, with some weekend work required, and you will document results in ALCOA+ data

Qualifications

• Bachelor’s degree in microbiology, Biology, Biotechnology, or related Life Science with 3+ years of hands‑on microbiology experience
• OR associate degree with 5+ years of hands‑on microbiology experience
• OR master’s degree with at least 1 year of GMP‑regulated microbiology experience

Responsabilités

• Perform routine and non-routine microbiological testing of raw materials, in-process samples, drug substance, and drug product
• Execute Bioburden Testing and Bacterial Endotoxin Testing (BET) per procedures and compendial requirements
• Support product release, stability studies, validation activities, and manufacturing operations
• Collect and trend utility monitoring samples from water systems, clean steam, and compressed gas systems
• Document activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity
• Identify opportunities for process improvements and laboratory efficiencies

Connaissances

Microbiology lab experience

GMP/GxP

Bioburden testing

Endotoxin testing

ALCOA+ data integrity

Formation

Bachelor’s degree in microbiology or related Life Science

Associate degree with related hands-on microbiology experience

Master’s degree in microbiology or related Life Science

Outils

LIMS

ELN

SAP

ERP

WebStatistica

Veeva

Description du poste

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:

• 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.

Why you?

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.

#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

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.

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.