At a Glance
- Tasks: Provide real-time QA support and ensure compliance with industry standards on the shop floor.
- Company: Join Boehringer Ingelheim, a Top Employer in the UK with a purpose-driven culture.
- Benefits: Enjoy career development opportunities and contribute to meaningful work that impacts lives.
- Other info: Fixed-term contract until December 2027 with excellent growth potential.
- Why this job: Make a difference in quality assurance while working in a dynamic manufacturing environment.
- Qualifications: Bachelor’s degree in a scientific field and relevant quality experience required.
The predicted salary is between 35000 - 45000 £ per year.
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 judgement, 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 organisational 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.
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.
QA Shop Floor Specialist employer: Boehringer Ingelheim GmbH
Boehringer Ingelheim is an exceptional employer, recognised as a Top Employer in the UK, offering a supportive work culture that prioritises employee well-being and professional growth. As a Senior ML Engineer in London, you will be at the forefront of biomedical AI, collaborating with leading scientists and engineers to make impactful contributions to human health while enjoying a hybrid work model that promotes work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land QA Shop Floor Specialist
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We think you need these skills to ace QA Shop Floor Specialist
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Boehringer Ingelheim GmbH!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Boehringer Ingelheim GmbH that you're not just a fit for the job but also a safety-conscious candidate!
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How to prepare for a job interview at Boehringer Ingelheim GmbH
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Boehringer Ingelheim GmbH that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Boehringer Ingelheim GmbH’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
