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Job Title: Senior QA Specialist

Job Number: 24048

Location: Lexington, MA

Job Description

The individual in this role shall be responsible for review and release of manufacturing/test documentation from manufacturing operations, i.e., review of EBRs, Deviations, CAPAs, etc. Writing and reviewing instructions, as needed, issuing CoAs/CoCs, interacting with CMO/CROs. Performing audit(s) of documentation and CMO/CROs as needed. Be an overall contributor to the QMS.   

Responsibilities

  1. Review and address any issues associated with GMP manufacturing of Product.
  2. Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
  3. Issue/Review documentation, i.e., Deviations, Investigations, CAPAs, OOS etc, as they occur.
  4. Assist or conduct training sessions as needed.
  5. Review and provide input in Quality Agreements, as applicable.
  6. Assist in internal/external audits, when needed.
  7. Assume additional responsibilities as assigned. 

Required Skills

  1. Minimum of five (5) years’ experience in GMP regulated industries – preferably     Pharma
  2. BA/BS in Life Sciences or additional relevant work experience.
  3. Hands on experience in GMP with a start-up pharma company
  4. Able to work independently and with a multi-disciplinary team.
  5. Excellent written and verbal communication skills
  6. Previous experience with Batch/Lot review and disposition in biotech/pharma
  7. Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.

 

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