Operational Quality Specialist

About the role

GSK is hiring an Operational Quality Specialist for an on-site position at a United States manufacturing site. The role provides operational quality oversight, working closely with production, laboratories, engineering and quality teams to keep processes compliant, safe and reliable, and to uphold cGxP standards through independent oversight of GxP processes.

Key responsibilities

• Ensure GMP processes and personnel follow current GMP, regulatory requirements and procedures, keeping inspection readiness at all times
• Provide shopfloor oversight and act as first line of contact for quality issues, escalations and quality decisions
• Guide GMP activities in real time to detect and prevent deviations and defects
• Spot-check production, testing, cleaning and maintenance activities
• Review and approve batch records, deviations, CAPA plans, change controls, validations, PQRs and customer complaint investigations, following ALCOA+ data integrity principles
• Make or recommend disposition decisions and support lot release
• Support self-inspections, internal audits and inspection readiness, and investigate quality issues with root cause analysis
• Coach employees on following procedures and the impact of non-compliance on product quality and patient safety

Required profile

• Bachelor's degree in biology, chemical engineering, life sciences, or another discipline with equivalent technical depth from experience
• 2+ years of experience in a regulated industry
• Strong quality assurance background and experience in pharmaceutical facilities, equipment and quality systems
• 1+ year of experience applying GMP, NIH Guidelines, FDA and other regulatory requirements to quality operations
• Experience with validation principles, aseptic processing, quality systems and FDA regulations
• Training in DMAIC root cause analysis and experience reviewing batch records and GMP documentation
• Biologics manufacturing experience strongly preferred

The role is on-site at a US manufacturing location with regular presence in production and laboratory areas. Applicants should describe how their experience fits the responsibilities and give examples of quality improvements delivered.