This specialist role supports Quality Control laboratory operations by providing technical, documentation, investigation, and project support to ensure compliant, efficient, and reliable laboratory performance. The position involves writing and reviewing laboratory procedures, leading quality investigations, and driving continuous improvement initiatives. It suits a professional who can represent the QC team on site-based projects and non-routine work.
Responsibilities
Write, update, review, and maintain Laboratory Standard Operating Procedures, Analytical Methods, Specifications, and related controlled documents in alignment with current Good Manufacturing Practice (GMP), regulatory, and site requirements
Serve as lead investigator for (Quality Control) QC-related Deviations, Laboratory Investigation Reports, Change Controls, and Corrective/Preventive Actions, ensuring timely, scientifically sound, and compliant record closure
Provide technical and quality support for laboratory operations, including data review, documentation practices, assay/process troubleshooting, and inspection readiness activities
Support initiatives to improve Quality Operations, laboratory efficiency, schedule adherence, right-first-time performance, and overall GMP performance
Lead continuous improvement and problem-solving activities for the QC team using appropriate tools to identify root causes, reduce waste, improve process robustness, and sustain improvements
Represent the QC team on site-based projects and cross-functional activities, including maintenance, shutdowns, non-routine work, laboratory readiness, and implementation planning
Partner with quality assurance (QA), Manufacturing, Engineering, Validation, MSAT, Supply Chain, and other stakeholders to assess quality impact, resolve issues, and implement sustainable actions
Support internal and external audit/inspection readiness by preparing documentation, providing SME input, responding to requests, and supporting execution of commitments
Provide guidance, coaching, and training to laboratory staff on procedures, documentation expectations, investigations, quality systems, and continuous improvement practices
Maintain awareness of applicable GMP, regulatory, safety, and site requirements and ensure assigned activities are performed in a compliant and safe manner
Requirements
Bachelor’s Degree in Biochemistry, Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related technical discipline or related experience
3+ years of experience in a Good Manufacturing Practice/ Good Practice (GMP/GxP) regulated laboratory, quality, manufacturing, or technical operations environment
Experience with laboratory investigations, controlled documents, quality systems, and continuous improvement is preferred
Master’s Degree in a Scientific, technical, quality, or laboratory-related discipline (preferred)
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Demonstrated leadership, ownership, and accountability for quality, technical, and operational deliverables (preferred)
Strong written and verbal communication skills, including the ability to produce clear, compliant, audit-ready documentation (preferred)
Effective problem-solving skills and ability to lead root cause analysis, Corrective and Preventive Action (CAPA) development, and continuous improvement activities (preferred)
Able to prioritize, manage timelines, make risk-based decisions, and implement actions in a complex, fast-paced environment (preferred)
Able to influence without authority and collaborate effectively across QC, QA, Manufacturing, Engineering, Validation, Manufacturing Science and Technology (MSAT), Supply Chain, and site support functions (preferred)
Solid team player able to work independently while supporting team-based laboratory operations and site priorities (preferred)
Knowledge of GMP, International Council for Harmonisation (ICH), Food and Drug Administration (FDA), and other applicable regulatory expectations for laboratory operations, analytical documentation, investigations, and quality systems (preferred)
Responsible for adhering to all applicable safety, quality, data integrity, and documentation requirements
Important Details
Work arrangements: predominantly on-site role, with limited remote work flexibility typically up to 1-2 days per week, subject to business needs and manager
About the Company
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. It aims to positively impact the health of 2.5 billion people by the end of the decade, focusing on innovation in specialty medicines and vaccines across respiratory, immunology and inflammation; oncology; HIV; and infectious diseases.
