Senior Quality Control Manager
1 day ago
Hobson Prior is partnering with a biotechnology company to find a Senior Quality Control Manager - QC Stability. In this role, you will oversee a stability program, ensuring compliance and managing sample management. You will also provide expert input into regulatory submissions and support troubleshooting assays to drive continuous improvement.
Please note that to be considered for this role, you must have the right to work in this location.
Key Responsibilities:
- Manage and maintain a compliant stability program, including sample management and identifying stability studies.
- Author stability protocols and reports, and maintain trending of all stability activities.
- Provide expert input into regulatory submissions.
- Support troubleshooting assays and ensure a low invalid rate, proactively finding solutions and implementing actions for continuous improvement.
- Oversee external vendors and contract testing facilities for QC Stability testing needs, providing technical support.
- Create and support the execution of stability programs for products.
- Recruit and direct the QC Stability team.
Requirements:
- Experience in a regulated work environment with good laboratory practices.
- Laboratory-based testing experience and management experience in a regulated environment.
- Strong analytical skills and technical experience, preferably with product and/or raw materials testing.
- Good statistical knowledge, including familiarity with statistical packages such as JMP.
For more information, please contact Hobson Prior.
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