Kedrion Biopharma is recruiting a Quality Assurance Officer (QAO) to join our Quality Assurance Operations team at our Elstree site. This is an excellent opportunity to take on a hands-on, site-based QA role within a highly regulated biopharmaceutical manufacturing environment.
Reporting to the QA Operations Shift Lead, you will act as the primary QA contact on shift, working closely with Manufacturing, Engineering, and Technical teams to ensure ongoing compliance with GMP requirements and site quality systems. The role offers broad exposure across operational areas and plays a key part in supporting day-to-day manufacturing activities.
This role is on a 24/7 shift and the hours are – 4 days on (7am to 7pm) and 4 days off, then 4 nights on (7pm to 7am) and 4 nights off working Monday to Sunday.
Duties & Responsibilities -
* Act as the primary Quality Assurance contact across site during the shift
* Manage quality incidents and deviations using TrackWise, including DRs, QIs and CAPAs
* Review and approve documentation, ensuring completeness and compliance
* Perform prompt review of Batch Process Records and Autoclave Batch Processing Records
* Conduct QA walk rounds, audits and inspections across manufacturing and support areas
* Perform QA AQL sampling for finished product inspection
* Support investigations, root cause analysis and error risk reduction activities
* Escalate product quality or patient safety concerns to QA Management as required
* Participate in regulatory, customer and internal audits
* Maintain accurate QA records and contribute to continuous improvement initiatives
Skills & Education to help you in the role -
* Experience in sterile aseptic filling and packaging environments
* Familiarity with TrackWise and LIMS systems
* Knowledge of UK/EU and US regulatory requirements
* Experience with continuous improvement tools and methodologies
* Degree-level qualification in a scientific discipline (or equivalent experience)
* Experience working in a regulated quality environment
* Strong knowledge of Quality Management Systems (deviations, CAPAs, root cause analysis)
* Understanding of GMP and GxP requirements
* Excellent attention to detail, organisational and time-management skills
* Confident communicator with the ability to work cross-functionally
* Competent with root cause analysis and error risk reduction tools
* Able to enter production facilities and work a 24/7 shift pattern
What We Offer -
If you are looking for an opportunity to join a growing international biopharmaceutical company working within a role supporting patient safety and product quality, with ongoing training and professional development then we’d love to hear from you.
* Pension
* Life Insurance
* On-site parking
* Subsidised canteen
* Employee discounts and cash back
* Family friendly policies
* Employee recognition programme
Please apply now for immediate consideration.
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