Quality Control Specialist
Make a positive impact, in a team where it means more.
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being ambitious, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
We're now looking to recruit a Quality Control Specialist who will work in the QC Microbiology group. As QC Microbiology Specialist you will act as a subject matter authority providing technical and analytical support to the Quality Control function within the Speke site in addition to the wider site and global AZ partners.
You'll be responsible for Environmental Monitoring Programme, instrumentation and methodology troubleshooting, non-routine analysis, and the evaluation, exploitation, and implementation of new technology. You'll lead significant Quality Control investigations and change programs including introduction of new methods and technologies.
You will have expert knowledge and understanding of the functional area and laboratory instrumentation, as well as Good Manufacturing Practice/Good Laboratory Practice.
We'll look to you to play a key role in coaching and mentoring and developing other team members and working cross departmentally to support the overall QC organisation.
What you'll do:
Provide expert technical knowledge and act as QC representative in meetings on and off site along with Global partners.
Hold responsibility for technical issue resolution both within and outside the team, removing obstacles and understanding issues whilst guiding solutions.
Provide leadership and technical knowledge, authors/ review/ approves QC documentation, Out Of Specifications (OOS) investigations, Non-conformance investigations, change controls, data trending and review and technical queries locally and for Global partners as the need arises.
Compilation and execution of key protocols and reports.
Act as designee for the QC shift Manger and /or QC Manager as appropriate.
Drive and lead change management, projects, and continuous improvement by supporting the implementation of new technology through method validation activities and the analytical technology transfer of QC methodology into and out of Operations.
Support internal and external regulatory audits.
Supplier relationship management with key Outside Testing Laboratories as appropriate.
Collaborates and works across QC functions to ensure specialist resource to support all critical QC activities.
Participates in Specialist forums to Share and standardise best practice and improve QC technical agility.
Essential Skills & Experience:
- Qualified to degree level/or equivalent in a scientific area
- Technical SME in a QC Field (or equivalent)
- Effective problem solving skills.
- Sound knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
- Knowledge and understanding of Quality systems such as Qualification/Validation, Change Management, Quality Risk Management
- Stability experience
- Knowledge of Stability ICH guidelines
- Knowledge of microbiology
So, what’s next…
Are you already imagining yourself in this role? Good, because we can’t wait to hear from you!
Competitive Salary and Benefits
Opening date: 29/11/2023
Closing date: 13/12/2023
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.