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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 the Document Control and Training programs.
Key Responsibilities- Maintain Good Manufacturing Practice (GMP) documentation and training systems in compliance with regulatory and quality requirements.
- Issue, process, distribute, and archive controlled documents, logbooks, laboratory notebooks, and Quality Control testing numbers.
- Ensure timely implementation of document change controls and timely release of documentation for production processes and associated activities.
- Manage Veeva Vault Training and Quality Docs modules, including administrative and configuration changes as required.
- Maintain employee training files, ensuring they are updated and reflective of employee training requirements.
- Provide effective training to new and existing staff on the Quality documentation and training programs.
- Maintain and report training metrics on a quarterly basis for management review meetings.
- Support internal and client audits as the subject matter expert for the Documentation and Training department and provide support as part of the Quality audit team.
- Bachelor's degree in Life Sciences preferred with a minimum of 8 years of experience working in a GMP environment or equivalent level of work experience in a GMP environment.
- Minimum of 2 years of experience within a document control and training function, preferably in a GMP environment.
- Previous experience in Veeva Vault Training and Veeva Quality Docs preferred.
- Experience in Microsoft Excel, PowerPoint, and Word required.
- Ability to lead teams and complete projects according to timelines.
- Effective time management skills and ability to adjust to and manage multiple tasks with changing priorities/assignments.
- Strong reasoning skills, organization, and problem-solving.
- High ethical standards, maintenance of confidentiality.
- 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 some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise.
We offer a competitive reward package, development opportunities, a welcoming and friendly work environment, and state-of-the-art laboratory and manufacturing facilities. We want you to feel inspired every day and succeed together through passion, commitment, and teamwork.
