Gsk
QC Scientist - Weekend Shift
USA - Pennsylvania - King of Prussia
Sponsorship not specifiedDetected 7 days ago
SAPProcurementERPInventory ManagementHRGMPFDA RegulatoryMedical DevicesProblem SolvingGxP
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).
Responsibilities
- Perform testing to support product release, stability studies, validation activities, and manufacturing operations.
- Accurately document laboratory activities and results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
- 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.
- 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.
Requirements
- Bachelor's degree in Microbiology, Biology, Biotechnology, or a related Life Science discipline with 3+ 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.
- 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.
- All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
Nice to have
- 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:
- Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Lean Management, Problem Solving, Quality Assurance (QA), Quality Control (QC), Risk Awareness, Testing Operations
- We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
Skills
- OR Associate degree in a scientific discipline with 5+ years of hands-on microbiology laboratory experience
- Experience working in a GMP/GxP-regulated pharmaceutical, biotechnology, medical device, or healthcare environment.
- Experience performing Bioburden and Bacterial Endotoxin Testing (BET).
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
- 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.
- GSK is an Equal Opportunity Employer.
- Important notice to Employment businesses/ Agencies
- GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
- This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.
- For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
Benefits
- respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
Equal opportunity
- 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 - usrecruitment.adjustments@gsk.com
This listing is sourced directly from Gsk's careers page and normalized into a canonical job model.