QA Shop Floor Specialist

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 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.

• 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
• Bachelorâs 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. TrackWise, 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

Boehringer Ingelheim is recognised as a Top Employer in the UK , reflecting our commitment to exceptional workplace standards, career development and a purpose-driven culture. Our employees contribute to meaningful work, creating long-term value for people, animals and the environment.

Learn more about why BI is a great place to work:
https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

Candidates may be asked to undergo a Basic Disclosure and Barring Service (DBS) Security check. Any offer of employment will be subject to satisfactory DBS certificate.