QA Shop Floor Specialist

QA Shop Floor Specialist

The QA Shop Floor Specialist plays a pivotal role in providing real-time Quality Assurance support within operational manufacturing environments. This position ensures compliance with EU GMP, biosafety, HSE requirements, and internal Boehringer Ingelheim standards. The role requires strong independent judgment, the ability to manage multiple priorities, and a proactive approach to identifying, assessing, and resolving quality events that may impact products and processes.

Through coaching and collaboration, this role also drives continuous improvement and promotes a strong and sustainable quality culture across the site.

This is a fully site-based position in Pirbright, offered on a fixed-term contract until 31 December 2027.

• Provide real-time QA support on the shop floor, ensuring compliance with GMP, data integrity, and internal standards
• Review and approve batch records and manufacturing documentation in line with right‑first‑time principles
• Support and lead investigations (deviations, discrepancies, OOX, complaints), including QA assessment and final approval
• Perform risk-based evaluations and ensure compliant handling of materials (e.g., quarantine, disposition)
• Review and approve CAPAs and change controls, ensuring quality, compliance, and effectiveness
• Support validation, qualification, and maintenance activities across manufacturing systems and processes
• Monitor QMS activities (deviations, CAPAs, change controls), ensuring timely closure and KPI adherence
• Identify trends and drive continuous improvement initiatives in collaboration with operational teams
• Ensure audit and inspection readiness, and actively participate in internal audits and regulatory inspections
• Support quality risk management activities and promote a strong quality culture across the site

Education

• Bachelor’s degree in a scientific or technical discipline
• Relevant Quality experience within a life sciences or related regulated industry

Skills & Experience

• Strong knowledge of EU GMP, Quality Assurance, and Quality Systems
• Experience in batch record review and documentation approval
• Hands‑on experience with deviations, investigations, CAPA, and change control processes
• Understanding of validation, qualification, and regulated manufacturing processes (e.g., aseptic processing, QC testing, sterilisation)
• Experience with electronic quality systems (e.g., Track Wise, e‑DMS or similar)
• Ability to apply regulatory and compliance requirements to complex situations
• Strong root cause analysis, risk assessment, and problem‑solving skills
• Ability to make independent, sound decisions in a fast‑paced environment
• Excellent organizational and prioritisation skills
• Strong communication skills (written and verbal) and ability to engage stakeholders at all levels
• Ability to coach and train operational teams
• High attention to detail and customer‑focused mindset