Senior QC & Quality Assurance Specialist (On-Site)

GSK; Marietta (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

GSK US Marietta site is seeking an on-site Quality Assurance professional to provide QA oversight for the QC laboratory, review of test records, and release activities for drug substance testing. You will lead investigations into deviations, support regulatory inspections, and ensure compliance with cGMP, GDP, and quality systems across the facility.

We value meticulous documentation, proactive problem solving, and the ability to coach and collaborate with cross-functional teams in a fast-paced

Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline; or equivalent experience.
• 2+ years of experience in a regulated QC laboratory or quality role in the life sciences industry.
• Experience with licensed biopharmaceutical or biological products with hands on experience using analytical lab equipment such as HPLC, GC-MS, TOC, FTIR, ELISA preferred.
• Experience with Aseptic Environmental Monitoring programs and microbiological testing methods (Sterility, Endotoxin, Bioburden).
• Experience in quality systems, QC laboratories, including validation, documentation, compliance in a high-volume release environment.
• Familiarity with GMPs, NIH guidelines, FDA requirements for validation and operations; GMP and GDP knowledge.
• Experience reviewing laboratory records and supporting investigations, deviations, or CAPA.
• On-site work capability with strong attention to detail and communication.

Responsibilities

• Provide operational QA oversight of the QC laboratory, including review and approval of test records, raw data, and COA activities.
• Perform on-floor lab walk-throughs to observe testing practices and coach teams on documentation and laboratory practices.
• Lead or support investigations into out-of-specifications, deviations, and laboratory incidents with root cause analysis and CAPA follow-through.
• Provide QA oversight to ensure compliance with cGMP, regulatory requirements, procedures, and product specs; support regulatory inspections.
• Oversee QC quality system activities and resolve/Elevate concerns including Deviations, CAPAs, Change Controls, Validation, Method Transfers, Risk Assessment, and PQRs.
• Provide guidance on cGMP and related QA issues to QC managers and personnel.
• Demonstrate familiarity with cGMPs, EHS procedures, and facility regulatory guidelines; ensure SOP compliance.
• Provide on-floor QA support and perform QA operations activities (documentation review, logbook review, cleaning records).
• Responsible for release of rooms after Return to Service testing and for status changes of lab areas due to maintenance or events.
• Oversee Stability and Retention program for the GSK Marietta site.

Skills

QC oversight

cGMP knowledge

Analytical testing

Documentation

Investigation skills

Regulatory compliance

Education

Bachelor's in Chemistry/related

Tools

HPLC

GC-MS

TOC

FTIR

ELISA

Job description

GSK US Marietta site is seeking an on-site Quality Assurance professional to provide QA oversight for the QC laboratory, review of test records, and release activities for drug substance testing. You will lead investigations into deviations, support regulatory inspections, and ensure compliance with cGMP, GDP, and quality systems across the facility.

We value meticulous documentation, proactive problem solving, and the ability to coach and collaborate with cross-functional teams in a fast-paced