Real-Time QA Specialist, Shop Floor & Compliance

Boehringer Ingelheim GmbH; Pirbright; Remote; GBP 42,000 - 60,000; Full time

Job summary

Boehringer Ingelheim is seeking a QA Shop Floor Specialist to provide real-time QA support on the manufacturing floor in Pirbright. This site-based, fixed-term role ensures compliance with EU GMP, data integrity, and internal standards while enabling rapid investigations and CAPA/changes management.

The successful candidate will review batch records, support QA assessments, and collaborate to drive continuous improvement and a strong quality culture across the site.

Qualifications

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

Responsibilities

• 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.

Skills

EU GMP knowledge

Quality systems understanding

Root cause analysis

Decision making

Organizational skills

Communication skills

Coaching / training

Attention to detail

Problem-solving

Stakeholder engagement

Education

Bachelor’s degree in scientific/technical discipline

Tools

TrackWise

e-DMS

Job description

Boehringer Ingelheim is seeking a QA Shop Floor Specialist to provide real-time QA support on the manufacturing floor in Pirbright. This site-based, fixed-term role ensures compliance with EU GMP, data integrity, and internal standards while enabling rapid investigations and CAPA/changes management.

The successful candidate will review batch records, support QA assessments, and collaborate to drive continuous improvement and a strong quality culture across the site.