Operational Quality Specialist
GSK
August 25, 2026
On-site
Marietta, PA
Operations
Position Summary:
You will provide operational quality oversight at a United States manufacturing site. Work with production, laboratories, engineering, and quality teams to keep processes compliant, safe, and reliable; maintain adherence to cGxP standards; provide independent oversight of GxP processes; maintain batch record review/approval, quality decision-making, and quality escalations; and liaise with QA Systems, QA Compliance, and QA Product Release (QAPR).
Responsibilities:
- Ensure GMP processes and personnel meet current GMP and applicable regulatory requirements; maintain inspection readiness.
- Provide shopfloor oversight; first contact for initial quality issue management and quality escalations.
- Observe GMP activities in real time to proactively detect potential quality issues and enable timely interventions.
- Perform spot-checks across production and laboratory areas (production, testing, cleaning, maintenance).
- Review cGMP documentation/data for ALCOA+ data integrity and GDP; review and approve batch records and related documentation.
- Review/approve deviations and associated CAPA plans; review documentation including procedural revisions, logbooks, PQRs, complaint investigations, change controls, and validation documents.
- Ensure GMPs, validation, quality, safety, and environmental regulations are met.
- Coach employees on compliance, procedure adherence, and patient safety impact.
- Support disposition/lot release and self-inspections/internal audits/inspection readiness.
- Review/approve GMP documentation updates (change controls, validation summaries); investigate quality issues and support root cause analysis and corrective/preventive actions.
Basic Qualifications:
- Bachelor’s degree in biology/chemical engineering/life sciences (or other discipline with technical depth).
- 2+ years in regulated industry; strong QA background; biologics manufacturing strongly preferred; experience in pharma facilities/equipment/quality systems.
- 1+ years with GMPs and NIH/FDA/other regulatory compliance.
- Validation principles, aseptic processing, quality systems, and FDA regulations; DMAIC training; batch record/GMP documentation review.
Preferred Qualifications:
- Biologics/pharma experience with deviations, CAPA, change control, and validation; root cause analysis methods (DMAIC or similar).
- Inspection readiness and regulatory expectations; ability to influence teams and coach on quality behaviors; fast-paced prioritization.
- Strong communication and interpersonal skills; foster “Quality Starts With Me” culture; continuous improvement.
How to apply:
Apply and explain how your experience aligns with the responsibilities and qualifications, including examples of quality improvements and how you supported teammates.
You will provide operational quality oversight at a United States manufacturing site. Work with production, laboratories, engineering, and quality teams to keep processes compliant, safe, and reliable; maintain adherence to cGxP standards; provide independent oversight of GxP processes; maintain batch record review/approval, quality decision-making, and quality escalations; and liaise with QA Systems, QA Compliance, and QA Product Release (QAPR).
Responsibilities:
- Ensure GMP processes and personnel meet current GMP and applicable regulatory requirements; maintain inspection readiness.
- Provide shopfloor oversight; first contact for initial quality issue management and quality escalations.
- Observe GMP activities in real time to proactively detect potential quality issues and enable timely interventions.
- Perform spot-checks across production and laboratory areas (production, testing, cleaning, maintenance).
- Review cGMP documentation/data for ALCOA+ data integrity and GDP; review and approve batch records and related documentation.
- Review/approve deviations and associated CAPA plans; review documentation including procedural revisions, logbooks, PQRs, complaint investigations, change controls, and validation documents.
- Ensure GMPs, validation, quality, safety, and environmental regulations are met.
- Coach employees on compliance, procedure adherence, and patient safety impact.
- Support disposition/lot release and self-inspections/internal audits/inspection readiness.
- Review/approve GMP documentation updates (change controls, validation summaries); investigate quality issues and support root cause analysis and corrective/preventive actions.
Basic Qualifications:
- Bachelor’s degree in biology/chemical engineering/life sciences (or other discipline with technical depth).
- 2+ years in regulated industry; strong QA background; biologics manufacturing strongly preferred; experience in pharma facilities/equipment/quality systems.
- 1+ years with GMPs and NIH/FDA/other regulatory compliance.
- Validation principles, aseptic processing, quality systems, and FDA regulations; DMAIC training; batch record/GMP documentation review.
Preferred Qualifications:
- Biologics/pharma experience with deviations, CAPA, change control, and validation; root cause analysis methods (DMAIC or similar).
- Inspection readiness and regulatory expectations; ability to influence teams and coach on quality behaviors; fast-paced prioritization.
- Strong communication and interpersonal skills; foster “Quality Starts With Me” culture; continuous improvement.
How to apply:
Apply and explain how your experience aligns with the responsibilities and qualifications, including examples of quality improvements and how you supported teammates.