Job Description
- Provide Quality oversight over the Quality System, including but not limited to the review SOPs, protocols, reports, data (including meta data) and records generated to support the manufacturing and distribution of product.
- Conducts timely Quality review of associated data, including data utilized to product release.
- Assists in complying with regulatory requirements related to product safety and quality.
- Ensures that procedures are being followed as outlined under FDA, ICH, Standard Methods, and the Quality System requirements.
- Review records to ensure data meets the industry requirements for data integrity.
- BS/BA Degree in a scientific discipline.
- 3+ years of experience with a Scientific background and/or experience in a GMP/GLP lab setting. Microbiology/Chemistry background preferred.