QC Scientist - Weekend Shift

GSK; King of Prussia (PA); On-site; USD 85,000 - 115,000; Full time

Job summary

GSK is seeking a QC Scientist – Microbiology to perform and support microbiological testing across materials and products in a GMP environment, with emphasis on Bioburden and Bacterial Endotoxin Testing (BET).

The role is on a Friday–Monday weekend shift, requiring independent work and collaboration with Quality, Manufacturing, and Technical Operations. 3+ years in microbiology and BET experience preferred.

Qualifications

• Bachelor's degree in Microbiology, Biology, Biotechnology or related Life Science with 3+ years hands-on microbiology lab experience.
• Associate degree in a scientific discipline with 5+ years hands-on microbiology lab experience.
• Master's degree in Microbiology, Biology, or related Life Science with ≥1 year hands-on microbiology in GMP environment.
• Experience in GMP/GxP-regulated pharmaceutical/biotech/healthcare environment.
• Experience performing Bioburden and Bacterial Endotoxin Testing (BET).

Responsibilities

• Perform routine microbiological testing of raw materials, in-process samples, drug substance, drug product, and EM/UM samples.
• Execute Bioburden and BET per approved procedures and compendial requirements.
• Support testing to assist product release, stability, validation, and manufacturing operations.
• Collect and test utility samples from water systems, clean steam, and compressed gas systems.
• Escalate quality or compliance concerns promptly to management.
• Document laboratory activities and results per cGMP, GDP and ALCOA+ data integrity principles.
• Identify opportunities for process improvements and lab efficiencies.
• Perform routine lab housekeeping and inventory management.
• Support method qualifications, method transfers, equipment qualifications, and validation activities as assigned.
• Perform other duties as assigned.

Skills

Data Integrity

Detail Orientation

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance

Quality Control

Risk Awareness

Testing Operations

Education

Bachelor's in Microbiology

Associate degree in Life Science

Master's in Microbiology

Tools

SAP/ERP

LIMS

ELN systems

Veeva

WebStatistica

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 operates on a Friday–Monday weekend shift schedule and requires the ability to work independently while effectively collaborating across Quality, Manufacturing, and Technical Operations.

Responsibilities

• Perform routine and non‑routine microbiological testing of raw materials, in‑process samples, drug substance, drug product, and 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.
• Perform 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.
• Experience using laboratory and quality systems such as SAP or ERP, LES/LES‑EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, and 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.

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.