Role responsibilities:
- Responsible for creating, review, and approve product/master builds in LIMS per 21CFR Part 11 & EU Annex 11 guidelines and regulations including appropriate data integrity.
- Included in the introduction of product/master builds, the individual will support by reviewing applicable documentation and make revisions and changes as required.
- Additionally, the individual will act as a software administrator for LIMS software when requested, not including management of user accounts and roles. The individual will also assist in the investigation of deviations as needed.
Education requirements:
BS or MS degree, life sciences
Work experience requirements:
- 3-5 years of GMP experience in pharmaceutical, biopharmaceutical or chemical industry
- Prior experience with analytical testing preferred.
- Prior data entry experience recommended.
Role Specific Competencies & Skills:
- Familiarity with general laboratory instrumentation and documentation.
- Working knowledge of laboratory management systems, LabVantage LIMS preferred.
- Prior Instrumentation testing experience is preferred