Real-Time QA Specialist - Shop Floor Quality & Compliance

Boehringer Ingelheim; Guildford; On-site; GBP 45,000 - 65,000; Full time

Job summary

The QA Shop Floor Specialist at Boehringer Ingelheim UK delivers real-time QA support on the manufacturing floor, ensuring EU GMP, data integrity and internal standards are met. You will work closely with operations to maintain product quality and compliance at all times.

You will review batch records, lead investigations, manage CAPAs and change controls, and monitor QMS activities to close issues promptly. A focus on continuous improvement and strong stakeholder communication is essential.

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 GMP compliance.
• Review and approve batch records and manufacturing documentation.
• Lead investigations (deviations, discrepancies, OOX, complaints) and approve QA actions.
• Perform risk-based evaluations and ensure compliant handling of materials.
• Review CAPAs and change controls for effectiveness and compliance.
• Monitor QMS activities and ensure timely closure of deviations and CAPAs.
• Identify trends and drive continuous improvement with operations.
• Ensure audit readiness and participate in internal/regulatory inspections.
• Support quality risk management and promote a strong quality culture.

Skills

EU GMP knowledge

Quality Assurance

Quality Systems

Batch record review

Deviations investigations

CAPA & change control

Risk assessment

Root cause analysis

Quality culture coaching

Communication

Education

Bachelor's degree in scientific/technical discipline

Tools

TrackWise

e-DMS

Job description

The QA Shop Floor Specialist at Boehringer Ingelheim UK delivers real-time QA support on the manufacturing floor, ensuring EU GMP, data integrity and internal standards are met. You will work closely with operations to maintain product quality and compliance at all times.

You will review batch records, lead investigations, manage CAPAs and change controls, and monitor QMS activities to close issues promptly. A focus on continuous improvement and strong stakeholder communication is essential.