QA Analytical Associate
5 days ago
**The Company**
**The role**
Reporting to the Vice President of Quality Assurance, the QA Analytical Associate will be responsible for the reviewing and approval of Analytical documents. This role will also involve the direct day to day support for the Analytics and the Immunology Departments. The role will report to the Director of Quality Assurance (UK) but will work very closely with the Director of Quality (USA) to provide support remotely where required.
Key areas of responsibility will include, but are not limited to:
- Review of stability protocols and reports
- Review and approval of Analytical Plans, Analytical Reports and Analytical data
- Review and QA approval of Out of Specifications (OOS), Out of Expectation (OOE), and Out of Trend (OOT)
- Review and QA approval of analytical SOPs and other related procedures
- Vaccitech review of third party/outsourced analytical data and Certificate of Analysis, including those used for drug product release
- Support the internal and external (supplier) audit schedule especially with reference to Laboratories
- Review Quality Technical Agreements in place between Vaccitech and External / third party laboratories
- Support the supplier approval and assessment for new and existing suppliers especially with reference to laboratories
- Review and QA approval of Analytical Specifications
- Review and QA approval of Method Validation protocols and reports
- Review and QA approval of Reference Standard qualifications and requalifications
- Providing support and data to the Leadership Quality Review Meetings where applicable
- To support earlier stage analytical development, including review of method qualifications, analytical equipment/instrument qualification, method transfer, etc.
- To support other QA activities in the CMC department such as batch record reviews, Quality Events (Deviations), for example
- Support the QA department in maintaining compliance with our Quality Management System (CAPAs, Quality Events, Change Control, SOP management)
**Experience and education required**
**What we can offer you**
Vaccitech is a great place to work. We encourage an entirely flat structure with an open-door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our business. This role would suit an experienced QC Chemist who wants to move into a QA career path. As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 6% pension contributions matched by the company.
**Notice to Recruiters
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