QC Scientist - Weekend Shift
GSK
August 06, 2026
On-site
King of Prussia, PA
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) per approved procedures and compendial requirements.
- Support product release, stability studies, validation activities, and manufacturing operations.
- Collect, test, review, and trend utility monitoring samples (pharmaceutical water systems, clean steam, compressed gas).
- Escalate quality/compliance concerns promptly.
- Accurately document results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
- Identify process improvements and laboratory efficiencies.
- Perform laboratory housekeeping and inventory management.
- Support method qualifications/transfers, equipment qualifications, and validation activities as assigned.
- Perform other duties as assigned.
Qualifications (Basic):
- Bachelor’s degree in Microbiology/Biology/Biotechnology or related life sciences with 3+ years hands-on microbiology laboratory experience.
- OR Associate degree with 5+ years hands-on microbiology laboratory experience.
- OR Master’s degree with at least 1 year hands-on microbiology experience in a GMP-regulated environment.
- Experience in a GMP/GxP-regulated pharmaceutical/biotech/medical device/healthcare environment.
- Experience performing Bioburden and BET.
Qualifications (Preferred):
- 3+ years in a GMP QC Microbiology Laboratory.
- Advanced compendial microbiology method experience (USP/EP/JP), ICH, and FDA expectations.
- SAP/ERP, LES/LES-EM, LIMS, WebStatistica, ELN systems, Veeva.
- Experience with investigations, CAPAs, deviations, and change controls.
Skills:
- Data Integrity, detail-oriented, digital fluency, GxP regulations, lean management, problem solving, QA/QC, risk awareness, testing operations.
- 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) per approved procedures and compendial requirements.
- Support product release, stability studies, validation activities, and manufacturing operations.
- Collect, test, review, and trend utility monitoring samples (pharmaceutical water systems, clean steam, compressed gas).
- Escalate quality/compliance concerns promptly.
- Accurately document results in compliance with cGMP, GDP, and ALCOA+ data integrity principles.
- Identify process improvements and laboratory efficiencies.
- Perform laboratory housekeeping and inventory management.
- Support method qualifications/transfers, equipment qualifications, and validation activities as assigned.
- Perform other duties as assigned.
Qualifications (Basic):
- Bachelor’s degree in Microbiology/Biology/Biotechnology or related life sciences with 3+ years hands-on microbiology laboratory experience.
- OR Associate degree with 5+ years hands-on microbiology laboratory experience.
- OR Master’s degree with at least 1 year hands-on microbiology experience in a GMP-regulated environment.
- Experience in a GMP/GxP-regulated pharmaceutical/biotech/medical device/healthcare environment.
- Experience performing Bioburden and BET.
Qualifications (Preferred):
- 3+ years in a GMP QC Microbiology Laboratory.
- Advanced compendial microbiology method experience (USP/EP/JP), ICH, and FDA expectations.
- SAP/ERP, LES/LES-EM, LIMS, WebStatistica, ELN systems, Veeva.
- Experience with investigations, CAPAs, deviations, and change controls.
Skills:
- Data Integrity, detail-oriented, digital fluency, GxP regulations, lean management, problem solving, QA/QC, risk awareness, testing operations.