Operational Quality Specialist -QC

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary:

Oversee all Quality Control (QC) SOPs, QC Methods, unplanned events, Change Controls, CAPAs, continuous method validation, and QMS events for drug substance quality control activities. Drive excellence in Quality Control.
Join us as an Operational Quality Specialist in Quality Control. You will be at the heart of ensuring high-quality standards are met across manufacturing and testing operations. Working closely with production, laboratories, engineering, and quality teams, you’ll protect product quality and patient safety through clear decisions and hands-on support. We seek proactive problem-solvers who communicate openly and foster a strong quality culture. This role offers you growth, learning, and a chance to contribute to GSK’s mission of uniting science, technology, and talent to get ahead of disease together.

Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Provide oversight to all QC related quality system activities and take initiative to resolve and/or escalate 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.

Principle Decisions and Complexity:

• Decisions made for Quality directly impact the quality and suitability of the products produced at the Marietta site including the release of clinical trial materials and commercial products. Decisions must be made in accordance with regulations of the USP, CFR, EP and FDA.
• Manage a high number of projects in parallel. Priorities can change very quickly due to new business opportunity or new sales projection. High adaptability required for ability to keep teams motivated when priorities change. Facilitate opposing views among departments to resolution.

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• 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 laboratory 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 USP<71>, Endotoxin testing USP<85>, 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.

…