QC Scientist - Weekend Shift

Biopharma Careers; King of Prussia (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

GSK in King of Prussia is seeking a QC Scientist – Microbiology to perform routine and non-routine microbiological testing for raw materials, in-process samples, drug substances/products, and environmental monitoring samples in a GMP setting.

The role focuses on Bioburden and Bacterial Endotoxin Testing (BET), with 80% hands-on testing and 20% lab support. Collaboration across Quality, Manufacturing and Technical Operations is expected.

Qualifications

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

Responsibilities

• Perform routine and non-routine microbiological testing of raw materials, in-process samples, drug substances/products, EM/UM samples
• Execute Bioburden Testing and BET per procedures and compendial requirements
• Support product release, stability studies, validation activities, and manufacturing operations
• Collect and test utility monitoring samples from water systems, clean steam, and gas systems
• Document activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity
• Identify opportunities for process improvements and lab efficiencies
• Perform housekeeping and inventory management in the lab
• Support method qualifications, transfers, equipment qualifications, and validation activities

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Quality Assurance (QA)

Quality Control (QC)

Risk Awareness

Testing Operations

Education

Bachelor's degree in Microbiology/Biology/Life Science

Associate degree in scientific discipline

Master's degree in Microbiology/Biology/Life Science

Tools

SAP/ERP

LES/LES-EM

LIMS

WebStatistica

Electronic Laboratory Notebook (ELN)

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 operates on a Friday–Monday weekend shift schedule and 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

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree in Microbiology, Biology, Biotechnology, or a related Life Science discipline with 3+ years of hands-on microbiology laboratory experience
• Associate degree in a scientific discipline with 5+ years of hands-on microbiology laboratory experience
• 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

If you have the following characteristics, it would be a plus:

• 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.
• Experience using laboratory and quality systems such as:

Skills

• Data Integrity
• Detail-Oriented
• Digital Fluency
• GxP Regulations
• Lean Management
• Problem Solving
• Quality Assurance (QA)
• Quality Control (QC)
• Risk Awareness
• Testing Operations

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.