Operational QC Lead - GMP & Compliance On-Site

Regulatory Jobs; Pennsylvania; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Benefits program

Job summary

GSK US is seeking an Operational Quality Specialist in Quality Control at our Marietta, GA site to uphold QC SOPs, methods, and CAPAs, ensuring product quality and patient safety across manufacturing and testing labs.

You will collaborate with production, laboratories, and engineering to drive quality improvements, perform on‑floor QA support, and apply cGMP standards in a fast-paced, matrix environment, contributing to GSK's mission to unite science and talent against disease.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline.
• 2+ years of quality control experience and overseeing QC testing.
• Experience with licensed biopharmaceutical or biological products preferred.
• Hands-on with analytical equipment (HPLC, GC-MS, TOC, FTIR, ELISA).
• Familiar with GMPs, FDA regulations, and quality systems.

Responsibilities

• Provide oversight to QC quality system activities and resolve quality concerns (CAPAs, deviations, change controls, validation, PQRs).
• Support on-the-floor QA activities and ensure compliance with GMP/EHS procedures.
• Release of rooms after Return to Service testing and QA oversight of stability/retention programs.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing

Lean Management

Pharma Regulations

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor's degree in Chemistry/Biochemistry/Pharm Sci

Tools

HPLC

GC-MS

TOC

FTIR

ELISA

LIMS

Job description

GSK US is seeking an Operational Quality Specialist in Quality Control at our Marietta, GA site to uphold QC SOPs, methods, and CAPAs, ensuring product quality and patient safety across manufacturing and testing labs.

You will collaborate with production, laboratories, and engineering to drive quality improvements, perform on‑floor QA support, and apply cGMP standards in a fast-paced, matrix environment, contributing to GSK's mission to unite science and talent against disease.