QC Supervisor

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

As a QC Lab Support Supervisor , you will provide leadership to Lab Support Team in order to manage non-testing processes within QC. This role includes: Sample Management, Stability, Compendial Review, QC Master Data/Monograph Creation, Auditing, Equipment Lifecycle, Performance Management. Ensure tasks are executed within SLA timelines. Drive projects to closure in support of site goals. Serve as owner for Lab Support Quality System Events. Ensure lab processes are safely executed and are compliant with GMP/regulatory requirements.

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

• Owner of non-testing processes within QC. Responsible for ensuring processes are optimized and meet regulatory requirements and that tasks are executed by team as per established schedules.

• Provide oversight to team to ensure Lab Support projects are well managed. Ensure team provide project updates and complete PMO related deliverables.

• Build relationships with global partners to identify and implement best practices, troubleshoot issues, share learnings, and align practices within the network. Ensure that methodology/documents are harmonized with other GSK sites as appropriate.

• Responsible for ensuring team manages QC equipment across lifecycle. Ensure team accurately represents Marietta site on the global ASAT team.

• Participate in regulatory audits and site investigations by acting as an SME. (Interpreting data, generating options, resolving problems, prioritizing solutions, selecting optimal solutions and implementing decisions) Support the timely resolution of audit findings or site investigations for QC related activities. Author and/or review associated documentation.

• Own Quality System Deviations/Events/Documents for Lab Support Team. Including, Laboratory Standard Operating Procedures, Analytical Methods, Unplanned Events, Change Controls, Specifications and other GMP documents such as monograph creation and revision.

• Ensure that methodology/documents are harmonized with other GSK sites as appropriate. Ensure all compendial sampling and testing is up to date with relevant compendia. Decide when changes are required to existing procedures, sampling plans and testing. Bring such issues to the attention of the QC supervisor/manager and other GSK sites as appropriate.

• Act as back-up for QC Manager and QC Planner.

We are looking for professionals with these required skills to achieve our goals:

• BS/BA degree in Microbiology, Chemistry, Biochemistry, or similar scientific discipline

• 5+ years' experience in a laboratory of a high volume, rapid turnaround testing.

• 5+ years' experience in a GMP/FDA regulated environment.

• 5+ years' experience in Quality Control environment in a Microbiology, chemistry or Biology field

If you have the following characteristics, it would be a plus:

• Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations, compliance and interfacing with auditors.

• Serve as an SME (subject matter expert) in technical areas in order to provide information to others.

• Ability to interface with regulatory auditors.

• Sense of urgency, flexibility, and accountability.

• Knowledge of SAP, LES, and Veeva.

• Executive capability and leadership to manage people and field projects teams.

• Must be a committed team player prepared to work in and embrace a team-based culture.

• Ability to follow written procedures and document results in a neat and precise manner.

• Intermediate computer skills required.

• Stay current on developments in the field and GSK-Bio Standards.

• Work within a multi-skilled team.

• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.

• Maintain a high level of integrity while balancing multiple priorities and responsibilities.

• Position may require employees to work in a rotational schedule. This schedule may include holidays, and weekends; over-time may be required.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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