At Rose BioSolutions, our capabilities span foundational research with human immune cells and stem cells to the complete advanced therapy manufacturing continuum. We are an established operation with a world-class team of experts, and we apply our R.O.S.E standard to every program and relationship: Reliable, Outcome driven, Scalable, and Excellent!
QA Officer (Systems)
This role will see you join the Keele site QA team reporting to the QA Leader (Systems). You will be responsible for maintenance of the site supplier assurance program. Maintenance of the internal and external audit programmes including, performing internal Audits, writing of internal Audit reports and agreeing appropriate CAPA. The role will also include working with the other departments on site reviewing and approving site training modules and role out.
Why Rose BioSolutions
At Rose, you are not just another layer in a large organization—you are a key contributor in a nimble, high-impact team. We offer:
- Direct exposure to diverse and complex client projects across multiple modalities.
- A collaborative, low-bureaucracy environment where ideas are heard and acted upon.
- Opportunities to grow your technical expertise and take ownership of your work.
- Close interaction with leadership and clients, enabling real influence on project outcomes.
Key Responsibilities
- Participate in the preparation of Vendor Risk Assessments
- Track, Monitor, and Maintain Vendor Qualification and Re-Qualification, and respective documentation
- Review Vendor Qualification Documentation and Vendor Change Notifications
- Maintain the Keele Approved Vendor List
- Archive all Qualification Documentation and Agreements
- Maintenance of Internal and External audit programmes
- Perform internal audits to ensure standards are being maintained to on site SOP’s and regulatory requirements.
- Authoring internal audit reports
- QA representative to support internal training initiatives and role out
- Support Change Control, Deviation and CAPA management
- Review and approval of Material Specification Sheets
- Good communication, both verbal and written
- High levels attention to detail
- Enthusiasm to look for process improvement ideas
- Proficient in Microsoft Word and Excel, strong administration skills
Experience (desirable but not essential)
- Understanding of GMP or other regulated environment
- Previous QA Experience
- Knowledge of Sharepoint, Smartsheet and SAP
Why Join Us?
- Impact: Every process we design is a step toward a cure. You’ll be making a real impact on the health of people in your community and across the globe.
- Expertise: Work alongside a world-class team of scientists and operational leaders in a “no-ego” environment.
- Stability & Growth: We offer the security of an established operation with the career growth opportunities of a rapidly expanding organization.
- Competitive base salary with performance-based bonus opportunities.
- Benefits to support and enhance your overall well-being.
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