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- Tasks: Support day-to-day manufacturing operations and ensure quality compliance in a dynamic environment.
- Company: Join a leading company in the biotech industry focused on quality and innovation.
- Benefits: Gain hands-on experience, competitive pay, and opportunities for professional growth.
- Why this job: Make a real impact on product quality while collaborating with diverse teams.
- Qualifications: Bachelor’s degree in a scientific field and 2 years of GMP experience required.
- Other info: 9-month contract with potential for career advancement in a supportive culture.
The predicted salary is between 30000 - 42000 £ per year.
The QA Associate, Quality Operations is a floor-facing Quality Assurance role that supports day-to-day manufacturing operations in a GMP-regulated environment. This position was opened due to increased team activity and requires strong collaboration with cross-functional partners across Manufacturing, Quality Control, Validation, Engineering, Facilities, and Materials. The role is ideal for an early-career QA professional with hands-on GMP experience who is comfortable working on the production floor and engaging with diverse teams.
Key Responsibilities
- Provide on-the-floor QA support to manufacturing operations, including area clearance, line clearance, and changeover activities to ensure production readiness.
- Support raw material processes, including review and approval of incoming material documentation and release for GMP use.
- Review and approve SOPs, Master Batch Records (MBRs), specifications, risk assessments, and other GMP documentation.
- Generate, revise, and maintain quality-related SOPs and controlled forms.
- Perform executed batch record review and approval to ensure accuracy, completeness, and compliance.
- Review and approve deviations, CAPAs, change controls, and associated investigations within the quality management system.
- Review and approve validation protocols, reports, and protocol executions in alignment with regulatory and site requirements.
- Review and approve QC laboratory qualification and equipment qualification documentation.
- Approve work orders in maintenance systems to verify equipment maintenance and calibration compliance.
- Support inspection readiness activities, partner audits, and regulatory inspections, including document retrieval and subject matter support.
- Collaborate closely with cross-functional teams to drive continuous improvement and promote a strong quality culture.
Technical Skills
- Experience using quality and enterprise systems such as: SAP (highly used), Veeva Vault (highly used), LIMS (plus), Infor / CMMS systems (nice-to-have).
- Proficiency in reviewing and managing GMP documentation and quality system records.
Qualifications & Experience
- Bachelor’s degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) required.
- Minimum of 2 years of professional GMP experience; 2–4 years preferred.
- Open to candidates with up to ~10 years of experience, provided GMP exposure aligns with the role scope.
- At least one role with direct, hands-on GMP experience.
- Experience supporting manufacturing or operational environments required.
- Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices (GDP).
9-month contract Administrative shift
QA Associate, Quality Operations employer: BioPharma Consulting JAD Group
Contact Detail:
BioPharma Consulting JAD Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land QA Associate, Quality Operations
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working in QA or GMP environments. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Get hands-on! If you can, volunteer or take on internships that give you real-world experience in GMP settings. This not only boosts your CV but also shows potential employers you're serious about the field.
✨Tip Number 3
Prepare for interviews by brushing up on your knowledge of cGMP regulations and quality systems. Be ready to discuss how you've applied these in past roles, as this will show you're the right fit for the QA Associate position.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who are proactive about their job search!
We think you need these skills to ace QA Associate, Quality Operations
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your hands-on GMP experience and any relevant roles you've had in manufacturing or quality assurance. We want to see how your background aligns with the QA Associate role, so don’t be shy about showcasing your skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality operations and how you can contribute to our team. We love seeing enthusiasm and a good understanding of the role, so let your personality come through.
Showcase Your Collaboration Skills: Since this role involves working closely with cross-functional teams, make sure to mention any experiences where you’ve successfully collaborated with others. We value teamwork, so highlight those moments where you’ve made a difference!
Apply Through Our Website: We encourage you to apply directly through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing candidates who take that extra step!
How to prepare for a job interview at BioPharma Consulting JAD Group
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and relevant regulations like 21 CFR Parts 210/211/11. Being able to discuss these confidently will show that you're not just familiar with the terms, but that you understand their importance in a QA role.
✨Showcase Your Collaboration Skills
Since this role involves working closely with cross-functional teams, prepare examples of how you've successfully collaborated in the past. Think about specific situations where you worked with manufacturing, quality control, or engineering teams to solve problems or improve processes.
✨Be Ready for Scenario Questions
Expect questions that put you in real-life scenarios related to QA operations. Practice responding to questions about how you would handle area clearance or manage deviations. This will help you demonstrate your practical understanding of the role and your problem-solving skills.
✨Prepare Your Questions
Interviews are a two-way street, so come prepared with thoughtful questions about the company's quality culture, team dynamics, and expectations for the role. This shows your genuine interest in the position and helps you assess if it's the right fit for you.
