On-Site Quality Assurance QC Specialist

GSK; Marietta (MS); On-site; USD 70,000 - 95,000; Full time

Job summary

GSK in the United States is seeking a Quality Control QC lead to oversee drug substance testing and laboratory control activities. You will work closely with QC analysts, lab leadership, manufacturing and quality teams to drive excellence in Quality Control.

This on-site role offers hands-on impact on product quality, opportunities to grow technical and leadership skills, and alignment with GSK’s mission to unite science, technology and talent to get ahead of disease together.

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; hands-on with analytical equipment (HPLC, GC-MS, TOC, FTIR, ELISA).
• Experience with aseptic environmental monitoring, microbiological testing (Sterility USP<71>, Endotoxin USP<85>, Bioburden).
• Strong GMP/GDP knowledge and ability to review lab records and CAPAs.

Responsibilities

• Provide operational QA oversight of the QC laboratory, including review of test records and certificates of analysis.
• Perform on-floor lab walk-throughs to observe testing practices and coach teams on documentation.
• Lead or support investigations into out-of-specifications, deviations and lab incidents; document root cause and CAPAs.
• Ensure compliance with cGMP and regulatory requirements; assist with regulatory inspections.
• Oversee QC-related quality systems and status changes for maintenance work or unplanned events.
• Advise QC managers on cGMP issues and quality assurance.

Skills

Data Integrity

GxP Regulations

Technical Writing

Quality Assurance

Problem Solving

Risk Awareness

Education

Bachelor's degree in chemistry

Tools

LIMS

HPLC

ELISA

Job description

GSK in the United States is seeking a Quality Control QC lead to oversee drug substance testing and laboratory control activities. You will work closely with QC analysts, lab leadership, manufacturing and quality teams to drive excellence in Quality Control.

This on-site role offers hands-on impact on product quality, opportunities to grow technical and leadership skills, and alignment with GSK’s mission to unite science, technology and talent to get ahead of disease together.