Operational Quality Specialist

Position Summary Provide operational quality oversight on site to help ensure safe, compliant and reliable supply. Work closely with production, laboratories, engineering and quality teams. This role offers hands‑on learning, visible impact on product quality, and career growth in a leading, mission‑driven organization. Responsibilities Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues. Accountable for quality decision making via work order assessments, atypical comments, and initial impact assessment for deviations. Provide on‑the‑floor quality oversight, perform regular shopfloor walk‑throughs, and detect early quality risks. Review executed and master batch records, deviations, and associated CAPA plans for completeness and compliance. Approve or recommend disposition decisions and support lot release activities under defined procedures. Support and perform self‑inspections, internal audits, and inspection readiness activities. Responsible for review, release and second check of batch record documentation for compliance and regulatory requirements. Ensure GMP documentation and records follow Good Documentation Practice (GDP) and data integrity principles through review and end‑user support. Provide timely guidance during GMP activities to proactively detect potential quality issues through active observation in real‑time, allowing for timely interventions to prevent deviations and defects. Perform a spot‑check of activities across defined GMP areas (production, testing, cleaning, maintenance) to ensure compliance with quality standards. Collaborate with cross‑functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts. Ensure facilities are maintained in a good state in line with local housekeeping standards and any deviation is escalated. Review and approve GMP documentation, including change controls, validation summaries, and procedural updates. Basic Qualifications Bachelor’s degree in a scientific, engineering, or technical discipline; or equivalent experience. 2+ years of experience in a regulated life sciences manufacturing or quality role. 1+ year of experience with Good Manufacturing Practices (GMP) and good documentation practices. 1+ year of experience reviewing batch records and GMP documentation. Preferred Qualifications Experience in biologics or pharmaceutical manufacturing environments. Experience with deviations, CAPA, change control, and validation activities. Training or experience in root cause analysis methods such as DMAIC or similar. Familiarity with inspection readiness and regulatory agency expectations. Ability to influence cross‑functional teams and coach others on quality behavior. Comfort working in a fast‑paced environment and prioritizing competing demands. Strong observational skills and the ability to make timely, clear quality decisions on the shopfloor. Clear written verbal communication skills and ability to work across teams. Work Arrangements This position is onsite only; hybrid or remote work is not allowed. Hours and Shifts First shift Monday through Thursday (4×10 hours). Availability and flexibility to work a normal shift Monday through Friday are required. Equal Opportunity Employer 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. #J-18808-Ljbffr GlaxoSmithKline