# QC Scientist – Microbiology

**Company**: GSK
**Location**: Pennsylvania - King of Prussia
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---King-of-Prussia/QC-Scientist_449751?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_bf888526-718

## 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).

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.

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.

- SAP or ERP, LES/LES-EM, LIMS, WebStatistica, Electronic Laboratory Notebook (ELN) systems, Veeva.

- Experience supporting investigations, CAPAs, deviations, and change controls.

Benefits:

- Comprehensive benefits program

#LI-GSK

## Skills

### Required
- Microbiology
- Biology
- Biotechnology
- GMP regulations
- GxP regulations
- Bioburden Testing
- Bacterial Endotoxin Testing

### Nice to have
- SAP
- ERP
- LES/LES-EM
- LIMS
- WebStatistica
- Electronic Laboratory Notebook (ELN) systems
- Veeva

---

Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---King-of-Prussia/QC-Scientist_449751?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)