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Lead Specialist, Document Control and Training
2 months ago
Oxford Biomedica is seeking a highly skilled Lead Specialist to join our US Quality Assurance Team. As a key member of our Quality Systems and Compliance team, you will be responsible for managing our Document Control and Training programs.
Key Responsibilities- Document Control: Maintain Good Manufacturing Practice (GMP) documentation and training systems in compliance with regulatory and quality requirements.
- Document Issuance and Distribution: Process, distribute, and archive controlled documents, logbooks, laboratory notebooks, and Quality Control testing numbers.
- Change Control: Ensure timely implementation of document change controls and release of documentation for production processes and associated activities.
- Veeva Vault Management: Manage Veeva Vault Training and Quality Docs modules, including administrative and configuration changes.
- Employee Training: Maintain employee training files, ensuring they are updated and reflective of employee training requirements.
- Training Delivery: Provide effective training to new and existing staff on Quality documentation and training programs.
- Training Metrics: Maintain and report training metrics on a quarterly basis for management review meetings.
- Audit Support: Provide support for internal and client audits as the subject matter expert for the Documentation and Training department.
- Education: Bachelor's degree in Life Sciences or equivalent experience in a GMP environment.
- Experience: Minimum 8 years of experience working in a GMP environment, with at least 2 years in a document control and training function.
- Skills: Experience with Veeva Vault Training and Veeva Quality Docs, Microsoft Excel, PowerPoint, and Word.
- Leadership: Ability to lead teams and complete projects according to timelines.
- Communication: Strong verbal and written communication skills.
Oxford Biomedica is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies to patients around the world. We collaborate with innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise.
We offer a competitive reward package, development opportunities, a welcoming and inclusive working environment, and state-of-the-art laboratory and manufacturing facilities.
