QC Scientist - Weekend Shift

GSK King Of Prussia, Pennsylvania, United States (on-site)

About the role

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
  • 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.

Requirements

• 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 with 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

Benefits

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

Schedule

Friday-Monday weekend shift schedule.