Quality Control Specialist - MES

GSK; Marietta (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

GSK in Marietta, PA seeks an experienced MES Quality Assurance professional to ensure adherence to cGxP standards through independent oversight of MES processes and QA activities. You will collaborate with manufacturing, engineering, IT and quality teams to maintain compliant, trustworthy data and drive continuous improvement.

The role offers hands-on learning, clear career growth, and alignment with our mission to unite science, technology and talent to get ahead of disease together.

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering or equivalent with technical depth
• Minimum 3 years' experience in a regulated industry, preferably Quality Assurance
• Prior MES implementation experience required
• Understanding of pharmaceutical facilities, equipment and systems to apply knowledge daily
• Experience with GMPs, FDA/regulatory compliance, validation principles and data integrity
• DMAIC root cause analysis training and experience
• 1+ year hands-on experience with GMP and GDP practices

Responsibilities

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure GMP compliance and readiness for inspections across quality, safety and environmental regulations.
• Review changes to master data, URS and design documents and validate impact on MES/QA processes.
• Approve validation forms, deviation investigations, CAPA plans, logbooks and PQRs.
• Coach teams on procedures, data integrity and compliance; promote a “Quality Starts With Me” mindset.
• Lead investigations for deviations and data anomalies; perform root cause analysis and CAPA follow-up.
• Support inspections, audits, and regulatory inquiries related to computerized systems.
• Monitor MES quality KPIs and drive process or system improvements.

Skills

Data Integrity

Detail Oriented

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharma Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Biology

Bachelor's degree in Chemical Engineering

Tools

LIMS

Electronic Batch Records

Job description

Business Introduction: We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

Business Introduction: We manufacture and supply reliable, high‑quality medicines and vaccines to meet patients’ needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

Position Summary: To ensure adherence to cGxP standards and procedures through the independent oversight of GxP processes. To improve the effectiveness of quality in preventing /identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. Directly support Operational through development, review, and approval of MES related design, implementation and performance management tasks. You will provide operational quality assurance for Manufacturing Execution System activities that support drug product manufacturing. You will work closely with manufacturing, engineering, IT, and quality teams to keep processes compliant and data trustworthy. We value clear decision makers who coach others and act with integrity. This role offers hands‑on learning, visible impact, and clear career growth aligned with our mission of uniting science, technology and talent to get ahead of disease together.

Responsibilities:

• Provide operational QA oversight for MES workflows, electronic batch records, and system-controlled manufacturing steps.
• Ensure that all GMP processes and operational personnel adhere to current GMP, validation, quality, safety and environmental regulations are met maintaining inspection readiness at all times.
• Review eCC, TCD and/or other QS change for impact to: Master Data (Equipment, sMBR, Workstations, Workcenters). Main-PI, Sub-PI design/validation
• Review and approve creation and/or updates to master data:
• Equipment Spec File (as QA Master Data) sMBR (as sMBR QA Reviewer) including integration with SAP and OsiPi
• Review and approve creation and/or updates to URS and Design of Main-PI, Sub-PI (as QA PI Reviewer and QA Ops, as applicable) Including integration with SAP and OsiPi
• Approval of Validation Form for Main-PI, Sub-PI pre and post-execution (as QA PI Reviewer) including applicable incident management and including integration with SAP and OsiPi
• GxP, DI, Business Continuity Risk Assessments, PI inventory
• IO/PQ protocol and report, including applicable validation impact assessment/unplanned events (as QA PI Reviewer and QA Ops, as applicable). Audit Trail Reviews
• Develop/Approve MES LSOPs and associated child documents
• Provide review, initial impact approval, and final approval of devations and associated CAPA plans, logbooks, PQRs, customer complaint investigations, change controls, validation documents, etc.
• Role model the GPS standards and foster a ‘Quality Starts With Me’ culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non‑compliance can have on product quality and patient safety.
• Perform regular shopfloor and system walkthroughs to identify risks and coach teams on good documentation and data integrity.
• Lead or support investigations for deviations, system incidents, and data anomalies, including root cause analysis and CAPA follow‑up. Review and approve change controls, validation summaries, and procedural updates that affect MES or digital records.
• Support inspection readiness, internal audits, and regulatory questions related to computerized systems and digital records.
• Monitor MES‑related quality KPIs and trends and recommend process or system improvements.

Basic Qualifications:

• Bachelor’s degree in Life Sciences, Biology, Chemical Engineering. A bachelor's degree in other disciplines may be acceptable if sufficient technical depth has been achieved from experience.
• Minimum 3 years' experience in regulated industry preferably in Quality Assurance.
• Must have prior MES implementation experience.
• Requires understanding and experience with pharmaceutical facility, equipment and systems. Including technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
• Experienced with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements sufficient to apply to quality operations and compliance, with knowledge of validation principles, aseptic processing, quality systems and FDA regulations.
• Training and work experience in DMAIC root cause analysis methodology.
• Must have 1 + year of hands‑on experience with Good Manufacturing Practices and Good Documentation Practices.

Preferred Qualifications:

• Experience in biologics manufacturing preferred.
• Familiarity with electronic records guidance such as 21 CFR Part 11 or Annex 11.
• Hands‑on experience supporting system validation (IQ/OQ/PQ) or computerized system lifecycle tasks.
• Experience with LIMS, electronic batch records, or other digital manufacturing solutions. raining and work experience in DMAIC root cause analysis methodology.
• Well‑developed interpersonal skills and decision‑making capabilities with the ability to influence different levels of the Site and Quality organization. Ability to deliver clear communications (written and verbally), coaching, foster a ‘Quality Starts With Me’ culture and work with a spirit of continuous improvement.
• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal quality solutions and implement decisions.
• Time management skills and ability to prioritize and respond to operational needs/issues within high paced environment.
• Training or experience in root cause analysis and CAPA methodologies. Demonstrated ability to influence cross‑functional teams and coach colleagues on quality and data practices.

#GSKCareers

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.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - [e-mail]

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.