Product & Process Compliance Specialist

GSK•Marietta, PA

5d•Onsite

About The Position

This role supports product and process compliance activities across a manufacturing site in the United States. The specialist will collaborate closely with operations, engineering, laboratory, regulatory, and quality colleagues. Key responsibilities include managing change control, investigating deviations, and maintaining inspection-ready quality systems. The position emphasizes practical problem-solving, clear communication, and a commitment to patient safety, offering hands-on experience, cross-functional exposure, and opportunities for career growth within GSK's mission.

Requirements

Associate degree in a science, engineering, quality, or related field, or equivalent experience.
Minimum 1+ year experience in a regulated life science, pharmaceutical, or biotech quality role.
Practical knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Experience with quality systems such as change control, deviations, CAPA, or document management.

Nice To Haves

Bachelor’s degree in a scientific, engineering, or quality discipline.
Experience in biologics or pharmaceutical manufacturing, laboratory operations, or secondary packaging.
Experience with electronic quality systems or document management tools (for example, Veeva Vault or similar).
Formal training in root cause analysis methodologies (for example, DMAIC, 8D).
Strong interpersonal skills and ability to work well across functions and levels.
Experience supporting validation, qualification, or Process Performance Qualification activities.
Demonstrated ability to perform root cause analysis and author investigation reports.
Strong attention to detail and ability to follow written procedures and deadlines.

Responsibilities

Lead end-to-end change control for process, equipment, and facility changes, ensuring timely approvals and robust documentation.
Investigate manufacturing deviations and quality events using structured root cause analysis and define effective corrective actions.
Review batch and laboratory records for completeness and compliance with procedures and regulatory expectations.
Support validation and qualification activities by linking change controls to DQ/IQ/OQ/PQ and related documentation.
Maintain and improve Quality Management System processes, including CAPA, document control, and periodic product review inputs.
Provide shop-floor coaching and practical guidance on good documentation practice, GMP, and data integrity.
Serve as the primary quality contact for assigned areas during production and project activities.
Evaluate risk and quality impact for proposed changes and support cross-functional risk assessments.
Prepare clear, inspection-ready change records, deviation reports, and investigation summaries.
Track and trend quality KPIs and provide inputs for site quality meetings.
Support internal audits and prepare summary reports, act as a subject matter contributor during external inspections.
Ensure quality obligations with third-party providers are managed and resolved promptly.