QA Shop Floor Specialist

Boehringer Ingelheim; Pirbright; On-site; GBP 40,000 - 55,000; Full time

Job summary

Boehringer Ingelheim in Pirbright, UK, seeks a QA Shop Floor Specialist to provide real-time QA support on the manufacturing floor, ensuring compliance with EU GMP and internal Boehringer standards. The role requires independent judgment, prioritisation of tasks, and proactive handling of quality events to protect products and processes.

This site-based, fixed-term position runs until 31 December 2027 and involves reviewing batch records, supporting investigations, CAPAs and change controls, and

Qualifications

• Bachelor's degree in a scientific or technical discipline.
• Relevant Quality experience within a life sciences or related regulated industry.
• Strong knowledge of EU GMP, QA, and QA systems.
• Experience with batch records review and documentation approval.

Responsibilities

• Provide real-time QA support on the shop floor, ensuring GMP compliance and data integrity.
• Review and approve batch records and manufacturing documentation.
• Support and lead investigations, including deviations and CAPA.
• Perform risk-based evaluations and ensure compliant handling of materials.
• Review and approve CAPAs and change controls, ensuring effectiveness.
• Support validation, qualification, and maintenance activities.
• Monitor QMS activities and ensure timely closure of issues.
• Identify trends and drive continuous improvement with operations.
• Ensure audit and inspection readiness and participate in internal/regulatory audits.
• Promote quality risk management and a strong quality culture.

Skills

EU GMP

Quality Assurance

Quality Systems

Batch record review

Deviations investigations

CAPA & change control

Problem solving

Regulated manufacturing

Education

Bachelor's degree in a scientific or 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.

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

TASKS & 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

REQUIREMENTS

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. 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

WHY THIS IS A GREAT PLACE TO WORK

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.

Our Company

Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,300 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at www.boehringer-ingelheim.com.

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com