Quality Control Operations Lead

GlaxoSmithKline; Marietta (PA); On-site; USD 90,000 - 115,000; Full time

Job summary

GlaxoSmithKline seeks an Operational Quality Specialist for its Marietta, PA site to oversee QC SOPs, methods, deviations, CAPAs, and Change Controls. You will drive quality decisions across production and testing, ensuring patient safety and product quality with hands-on QA support.

The role collaborates with production, labs, engineering, and quality teams to uphold GMP standards, with emphasis on problem-solving, documentation, and regulatory compliance.

Qualifications

• Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related field.
• 2+ years of quality control experience and experience overseeing quality control testing.
• Hands-on experience with analytical equipment such as HPLC, GC-MS, TOC, FTIR, ELISA; knowledge of GMP and QA practices.
• Understanding of GMP, FDA regulations, and quality systems; ability to drive initiatives across multiple teams.
• Strong communication and problem-solving skills; capable of working in a complex matrix environment.

Responsibilities

• Provide oversight to QC quality system activities including Deviations, CAPAs, Change Controls, Validation, Analytical Method Transfers, Risk Assessment, and PQRs.
• Provide on-the-floor QA support and perform QA operations (documentation review, logbook review, etc.).
• Responsible for release of lab areas after Return to Service testing and QA oversight of Stability and Retention program at the Marietta site.

Skills

Data Integrity

Detail-Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance (QA)

Risk Awareness

Technical Writing

Education

Bachelor's degree in chemistry, biochemistry, pharmaceutical sciences, or related field

Tools

HPLC

GC-MS

TOC

FTIR

ELISA

LIMS

Electronic Lab Notebooks

Job description

GlaxoSmithKline seeks an Operational Quality Specialist for its Marietta, PA site to oversee QC SOPs, methods, deviations, CAPAs, and Change Controls. You will drive quality decisions across production and testing, ensuring patient safety and product quality with hands-on QA support.

The role collaborates with production, labs, engineering, and quality teams to uphold GMP standards, with emphasis on problem-solving, documentation, and regulatory compliance.