Operational Quality Specialist

Responsibilities

• This role will provide YOU the opportunity to lead key activities to progress YOUR career.
• These responsibilities include some of the following: 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.
• Ensuring GMP documentation and records follow Good Documentation Practice (GDP) by adhering to principles for data integrity through both 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 to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities.
• Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
• Ensure facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated.
• Review and approve GMP documentation, including change controls, validation summaries, and procedural updates.
• This role is on-site at a United States manufacturing location and requires regular presence in production and laboratory areas.
• We welcome applicants who are collaborative, curious, and committed to continuous improvement.
• We are committed to inclusion and want people who will help create a respectful, supportive workplace

Basic Qualifications

Preferred Qualifications

• If you have the following characteristics, it would be a plus: 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 and does not allow any hybrid or remote work.
• You will be expected to be onsite for this role.
• Hours and Shifts: This is 1 st shift Monday through Thursday (4x 10 hours) but you will need to be available and flexible to work a normal shift Monday through Friday.
• How to apply: If this role matches your skills and ambitions, we encourage you to apply.
• Tell us how your experience fits the responsibilities and qualifications.
• Share examples of the quality improvements you have delivered and how you supported teammates.
• We look forward to hearing from you and exploring how you can help make a real difference for patients.
• Skills Data Integrity, Detail-Oriented, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Quality Assurance (QA), Risk Awareness, Technical Writing Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
• 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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• This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity
• 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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