This position is responsible for reviewing and approving Deviations/Investigation reports.
Coordinate and review various applicable Quality Systems documentation applicable to the Manufacturing area(s) being supported (Including but not limited to: Change Controls, Deviations, Validation, Documentation, Logbook Review, Batch Records associated with Manufacturing, other GMP documentation as applicable. Customer Lead and Interactions with customers required. Attend various quality meetings as assigned.
Participate in Customer and/or Regulatory Audits or meetings as needed.
On call rotation support as needed.
Cross-training into other additional QA support functions as needed. Various other duties as assigned
Requirements:

A Bachelor's degree in a science field is preferred with 5 years of experience in a biotech environment.
Good computer skills using standard microsoft office.
Strong written and verbal communication skills.
Excellent organizational skills and attention to detail important.
Strong Teamwork
Must be able to work with minimum supervision.
Trackwise Knowledge a plus