THE POSITION
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.
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.
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.