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- Tasks: Lead quality assurance for aseptic manufacturing and packaging on the night shift.
- Company: Join AstraZeneca, a leader in healthcare innovation and patient safety.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety and product excellence in a dynamic environment.
- Qualifications: Degree in a scientific discipline and experience in quality assurance.
- Other info: Embrace a collaborative culture with endless opportunities for development.
The predicted salary is between 36000 - 60000 £ per year.
Location: Macclesfield
Competitive salary and benefits
Introduction to role
Are you ready to make a significant impact in the world of aseptic manufacturing and packing? The Senior Specialist – Quality Assurance is accountable for delivering QA leadership and oversight for aseptic manufacturing and packaging operations on the night shift. You will provide GMP and aseptic processing expertise, assure cleanroom compliance, influence operational decisions within the Process Execution Team (PET), and support timely and compliant product release. This role is pivotal in safeguarding patient safety, regulatory compliance, and value stream performance.
Accountabilities
- Cleanroom and Aseptic Oversight: Provide technical guidance on cleanroom standards, aseptic techniques, and environmental controls aligned to current EU GMP Annex 1 and internal procedures.
- Deviation and CAPA Management: Advise on deviations, lead or contribute to root cause analysis, and agree CAPAs to prevent recurrence and improve process robustness.
- Product Quality/Release Support: Support or perform product release activities as required, ensuring batch documentation, data integrity, and compliance.
- GMP Training and Coaching: Complete required PET GMP training and coach manufacturing personnel on cGMP, aseptic behaviours, data integrity, and contamination control.
- Compliance and Continuous Improvement: Proactively identify compliance risks and opportunities for business improvement, efficiency savings, and lean optimization.
- Change Control: Lead or support local/cross-functional change controls ensuring validated state and regulatory alignment.
- Quality Systems Execution: Contribute to PQR, quality risk management, metrics (e.g., deviations, CAPA effectiveness), and documentation updates.
Essential Skills/Experience
- Degree (or equivalent) in a scientific discipline (e.g., pharmacy, microbiology, chemistry, biochemistry, engineering).
- A clear, comprehensive grasp of the quality assurance function, along with a strong understanding of other business functions and how they work together to achieve business objectives in a lean manufacturing environment.
- Quality Assurance in Pharmaceutical Manufacture with strong understanding of cross-functional operations in a lean environment.
- Aseptic Processing or Packing knowledge, including cleanroom behaviours and contamination control principles.
- Current GMP Knowledge and working familiarity with EU GMP Annex 1, ICH Q9/Q10, and data integrity principles.
- Communication and Influencing skills with cultural awareness; ability to coach operators and technicians.
- Decision-Making within general operating guidelines using risk-based, science-led judgment.
- Permanent Night Shift availability.
Desirable Skills/Experience
- Experience in Aseptic Manufacturing operations and sterile packaging lines.
- Microbiology Experience, including environmental monitoring, sterility assurance concepts, and interpretation of microbiological data.
- Quality Risk Management application (FMEA, HACCP).
At AstraZeneca, we are committed to quality that goes beyond compliance—driven by a proactive, science-based approach that prioritises patient safety and product excellence. We foster an inclusive community where collaboration is key, allowing us to innovate and adapt swiftly. With a focus on growth and innovation, you'll find endless opportunities to develop your expertise and contribute to groundbreaking advancements in healthcare!
Ready to take on this exciting challenge? Apply now and be part of a team that makes a real difference!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Date Posted: 09-Feb-2026
Closing Date: 23-Feb-2026
Our mission to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
Senior Specialist - Quality Assurance (Night shift) in Macclesfield employer: AstraZeneca
Contact Detail:
AstraZeneca Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist - Quality Assurance (Night shift) in Macclesfield
✨Tip Number 1
Network like a pro! Reach out to current employees at AstraZeneca or similar companies on LinkedIn. A friendly chat can give us insider info and might even lead to a referral!
✨Tip Number 2
Prepare for the interview by brushing up on your GMP knowledge and aseptic processing techniques. We want to show that we’re not just familiar with the basics, but that we can also bring valuable insights to the table.
✨Tip Number 3
Practice common interview questions related to quality assurance and compliance. We can even role-play with a friend to get comfortable with our responses and ensure we come across as confident and knowledgeable.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure our application gets noticed. Plus, it shows we’re genuinely interested in being part of the AstraZeneca team.
We think you need these skills to ace Senior Specialist - Quality Assurance (Night shift) in Macclesfield
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Specialist – Quality Assurance role. Highlight your experience in quality assurance, aseptic processing, and any relevant GMP knowledge. We want to see how your skills align with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Be sure to mention specific experiences that relate to the job description.
Showcase Your Technical Skills: Don’t forget to highlight your technical expertise in cleanroom standards and contamination control principles. We’re looking for someone who can provide guidance and support in these areas, so make it clear how you fit the bill!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates from our team!
How to prepare for a job interview at AstraZeneca
✨Know Your GMP Inside Out
Make sure you brush up on your Good Manufacturing Practice (GMP) knowledge, especially the EU GMP Annex 1. Be ready to discuss how you’ve applied these principles in past roles, particularly in aseptic manufacturing and cleanroom environments.
✨Showcase Your Aseptic Expertise
Prepare to talk about your experience with aseptic processing and contamination control. Think of specific examples where you’ve influenced operational decisions or improved compliance within a team, as this will demonstrate your hands-on knowledge.
✨Be Ready for Problem-Solving Questions
Expect questions around deviation and CAPA management. Have a couple of scenarios in mind where you successfully led root cause analysis or implemented corrective actions. This shows your proactive approach to quality assurance.
✨Communicate Effectively
Since this role involves coaching and influencing others, practice articulating your thoughts clearly. Prepare to discuss how you’ve trained or mentored colleagues in GMP and aseptic behaviours, highlighting your communication skills and cultural awareness.
