Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Support sterility assurance and training for manufacturing operations, ensuring compliance with quality standards.
- Company: Join CSL Seqirus, a leader in the pharmaceutical industry with a commitment to innovation.
- Benefits: Gain valuable experience in a dynamic environment with opportunities for professional growth.
- Other info: 12-month fixed-term contract with potential for career advancement.
- Why this job: Make a real impact on product safety and quality while working with a passionate team.
- Qualifications: Bachelor's degree in a scientific discipline and 3-5 years of quality systems experience.
The predicted salary is between 35000 - 45000 £ per year.
Under direction from the Senior Sterility Assurance Site Lead, this role provides sterility assurance support and training for the Seqirus Liverpool site as well as all third-party manufacturing facilities that perform manufacturing activities on behalf of Liverpool. Ensures that from an aseptic perspective, the day to day manufacturing operation runs in accordance with its validated status, all SOPs, the Quality manual and Good Manufacturing Practice.
Responsible for authoring and owning Environmental Monitoring trend reports, owning and facilitating aseptic training and gowning qualification, and assisting in manufacturing investigations due to microbiological excursions, such as out of specification results, objectionable organism recoveries and breaches of the sterile boundary. Associate works closely with manufacturing area managers to identify adverse trends and establish and implement corrective actions.
Responsibilities- Under general supervision, provides support on Quality systems to ensure compliance with company standards and GMP regulatory guidelines.
- Author Environmental Monitoring trend reports with detailed analysis and interpretation of the data. Ensure that all operational areas are aware of results and trends, with opportunity to contribute to root cause investigations.
- Develop, maintain and improve GMP-related gowning qualification programs including standard operating procedures (SOPs).
- Support quality systems related to Validation, Deviation Management, CAPA, Change Control, and Enterprise Learning Management.
- Collect, collate, evaluate, and report on Environmental Monitoring performance data of assigned business areas.
- Participate in internal and external audits and assist with 3rd party supplier audits; implement continuous improvement projects.
- Collaborate to resolve technical sterility assurance issues, provide aseptic training and communicate best practices.
- Bachelor degree in a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.) or Engineering.
- 3-5 years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environment.
- Experience of aseptic processes and sterility assurance preferred.
- Knowledge of current Good Manufacturing Practices (cGMP).
- Knowledge of FDA and EMA requirements.
This position is available as a 12-month secondment opportunity.
Sterility Assurance Specialist (12 Month Fixed-Term Contract) employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sterility Assurance Specialist (12 Month Fixed-Term Contract)
✨Tip Number 1
Network like a pro! Reach out to professionals in the sterility assurance field on LinkedIn or at industry events. We can’t stress enough how valuable personal connections can be in landing that dream job.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and aseptic processes. We recommend practising common interview questions and even doing mock interviews with friends to boost your confidence.
✨Tip Number 3
Showcase your expertise! Bring along examples of your previous work, like Environmental Monitoring trend reports or training materials you've developed. This will help us see your hands-on experience and how you can contribute.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team.
We think you need these skills to ace Sterility Assurance Specialist (12 Month Fixed-Term Contract)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Sterility Assurance Specialist role. Highlight your experience in quality systems and aseptic processes, and don’t forget to mention any relevant training or certifications that align with the job description.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about sterility assurance and how your background makes you a perfect fit for the team. Be sure to reference specific responsibilities from the job description to show you’ve done your homework.
Showcase Relevant Experience: When filling out your application, focus on showcasing your 3-5 years of experience in a cGMP regulated environment. Mention any specific projects or achievements that demonstrate your expertise in environmental monitoring and compliance with GMP standards.
Apply Through Our Website: We encourage you to apply through our website for the best chance of success. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at CSL
✨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practices (GMP) and how they apply to sterility assurance. Be ready to discuss specific examples from your past experience where you've ensured compliance with these standards.
✨Prepare for Technical Questions
Expect questions about aseptic processes and environmental monitoring. Review your understanding of microbiological excursions and be prepared to explain how you've handled similar situations in the past.
✨Showcase Your Training Skills
Since this role involves training others, think of examples where you've successfully trained colleagues or improved training programmes. Highlight your ability to communicate complex information clearly and effectively.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss how you've identified adverse trends and implemented corrective actions in previous roles. Use the STAR method (Situation, Task, Action, Result) to structure your answers and showcase your analytical skills.