Lead Specialist, Document Control and Training
2 weeks ago
Oxford Biomedica is seeking a highly skilled and experienced Lead Specialist to join our US Quality Assurance Team. As a key member of our team, you will be responsible for managing the Document Control and Training programs, ensuring compliance with regulatory and quality requirements.
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 files 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.
- Provide support for 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 is preferred with a minimum of 8 years of experience working in a GMP environment or the 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 is preferred.
- Experience in Microsoft Excel, PowerPoint, and Word is required.
- The ability to lead teams and complete projects according to timelines.
- Effective time management skills and the 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. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.
Oxford Biomedica collaborates with some of the world's most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. Oxford Biomedica's world-class capabilities span from early-stage development to commercialization. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.
What's in it for you- Competitive reward packages
- Development opportunities
- Welcoming, friendly, supportive colleagues
- A diverse and inclusive working environment
- State-of-the-art laboratory and manufacturing facilities
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