Quality Control Excellence Specialist

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

Job summary

GSK in Marietta, PA seeks an Operational Quality Specialist for Quality Control to oversee QC SOPs, methods, deviations, CAPAs, and validation. You will partner with production, laboratories, engineering and quality teams to protect product quality and patient safety with decisive, hands-on support.

Join a team applying GMP standards and QA practices to maintain high-quality manufacturing and testing operations. This role requires on-site presence at a U.S.

Qualifications

• Bachelor’s degree in chemistry, biochemistry, pharmaceutical sciences, or related scientific discipline.
• 2+ years of quality control experience and experience overseeing quality control testing.
• Prior experience with licensed biopharmaceutical or biological products preferred.
• Hands on experience using analytical lab equipment/systems, such as HPLC, GC-MS, TOC, FTIR, ELISA is preferred.
• Hands on experience with Aseptic Environmental Monitoring programs, microbiological testing methods, such as Sterility test USP71, Endotoxin testing USP85, Bioburden testing.
• Experience in quality systems, Quality Control Laboratories, including validation, documentation, compliance in a high volume, rapid turnaround release office or compliance department.
• Understanding of industry and science practices related to the business.
• Versed in GMP’s, NIH Guidelines, FDA and other regulatory agency requirements for validation and operations, analytical and stability functions and compliance.
• Demonstrated ability to drive initiatives across multiple business units under tight deadlines.
• Strong communication and problem‑solving skills with demonstrated ability to work well with and influence others without direct reporting relationships.
• Ability to work in a high complex matrix environment with a sense of urgency, flexibility and accountability.
• Must be a committed team player prepared to work in and embrace a multi‑skilled team‑based culture.
• Proven record of providing excellent internal and external customer service.
• Stay current on developments in the field and GSK- Standards.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• This role is responsible for approving GMP quality control test methods for drug product and must understand the requirements for documentation related to QC testing.

Responsibilities

• Provide oversight to all QC related quality system activities and take initiative to resolve and/or escape concerns including Deviations, CAPAs, Change Controls, Validation, Analytical Method Transfers, Risk Assessment, and PQRs.
• Provide advice and counsel on cGMP and related quality assurance issues to QC managers and personnel.
• Demonstrated familiarity and compliance with GMPs,EHS procedures and regulations, facility regulatory guidelines and standard operating procedures.
• Provide on the floor QA support and perform QA Operation's activities (documentation review, logbook review, facility cleaning records for quarterly walkthroughs).
• Responsible for release of the rooms after the Return to Service testing for the lab areas and for status changes of lab areas in response to maintenance work or unplanned events.
• Responsible for QA oversight of the Stability and Retention program for the GSK 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

Tools

LIMS

Analytical lab equipment (HPLC/GC-MS/TOC/FTIR/ELISA)

Job description

GSK in Marietta, PA seeks an Operational Quality Specialist for Quality Control to oversee QC SOPs, methods, deviations, CAPAs, and validation. You will partner with production, laboratories, engineering and quality teams to protect product quality and patient safety with decisive, hands-on support.

Join a team applying GMP standards and QA practices to maintain high-quality manufacturing and testing operations. This role requires on-site presence at a U.S.