- Maintains and develops effective quality and documentation systems appropriate for a Discovery setting Coordinates and ensures appropriate documentation for the Vaccine Discovery Clinical Testing Laboratory
- Write and review standard operating procedures (SOPs), laboratory procedures, equipment instructions, knowledge- based documents and business policies.
- Audit reports and aid in preparation of documents for submission to Quality Assurance and regulatory agencies.
- Ensure data and reports are in compliance with regulatory standards, applicable SOPs, policies, procedures.
- Generate document templates for general use. Create laboratory records, equipment records and log books
- Coordinate clinical sample handling, chain of custody, and tracking records Submit data and reports to Regulatory for inclusion in dossiers.
- Manage discovery documents and training in CLIX, a learning management system (LMS), to help plan, deliver and assess training.
- Train technical staff and management in quality and documentation procedures, including good documentation practices, handling and review of electronic laboratory notebooks, data and reports.
- Assist with internal inspections and ensuing corrective/preventative actions.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- B.S degree in a scientific discipline with 2+ years laboratory experience, preferably in a clinical testing laboratory, Quality, R&D or Discovery
- Must have experience working in a GXP environment
- Experience with Electronic Laboratory Notebooks is desirable
- Familiarity with regulatory processing and submissions.
- Must have experience writing and reviewing technical documentation, ideally have experience with advanced functions of Microsoft Word.
- Experience working with and training cross functional groups.
- Must be creatively open to new ideas and methods and work with a spirit of continuous improvement and innovation.
- Must have a comprehensive understanding of good documentation practices and strong attention to detail.
- Ability to identify, report, and seek prompt corrections as they arise.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
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