On-Site QA/QC Specialist: Lab Quality Lead

Biopharma Careers; Marietta (GA); On-site; USD 90,000 - 140,000; Full time

Job summary

GSK in Marietta, GA seeks a QA professional to provide quality oversight for drug substance testing and laboratory control activities. You will collaborate with QC analysts, lab leadership, manufacturing, and quality teams to drive product quality and regulatory readiness.

The 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 discipline.
• 2+ years in a regulated QC laboratory or quality role in life sciences.
• Experience with licensed biopharmaceutical or biological products and lab equipment (HPLC, GC-MS, TOC, FTIR, ELISA).
• Experience with GMPs, GDPs, quality systems, validation, and documentation in high-volume release environments.
• Strong attention to detail, clear written and verbal communication, on-site work.

Responsibilities

• Provide QA oversight of the QC lab, review test records, raw data and COAs.
• Conduct on-floor lab walkthroughs to observe testing and coach teams on documentation and practices.
• Lead investigations into deviations, root cause analysis and CAPAs.
• Ensure compliance with cGMP, regulatory requirements, procedures and specs; support inspections.
• Oversee QC quality systems activities and resolve concerns (deviations, CAPAs, validation, transfers).
• Advise QC managers on cGMP issues and best QA practices.
• Maintain familiarity with GMP, NIH guidelines, FDA requirements and GDPs.
• Provide on-the-floor QA support and perform QA operation duties (documentation review, logbooks, cleaning records).
• Manage room releases after Return to Service testing and status changes due to maintenance.

Skills

Attention to detail

Communication

GxP regulations

Technical writing

Problem solving

Education

Bachelor's degree in chemistry

Tools

HPLC

GC-MS

TOC

FTIR

ELISA

Job description

GSK in Marietta, GA seeks a QA professional to provide quality oversight for drug substance testing and laboratory control activities. You will collaborate with QC analysts, lab leadership, manufacturing, and quality teams to drive product quality and regulatory readiness.

The 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.