Agenus

QA Senior Specialist

US-MA-Lexington
Job ID
2017-1286
Category
Quality

Responsibilities

Provide daily operational support for all Quality functions including issuance and tracking of Quality Systems (OOS, Deviation, MRB, EMIs, etc.)and batch records, provide GMP and core competency training, review of quality data (validation, stability, batch analysis, environmental, etc.) and disposition of raw materials, intermediates and final product. Perform and/or assist in quality investigations related to manufacture of product. Executes required data audits and trending to support GMP manufacture and validation. Ability to perform risk assessments associated with Quality Systems. Other duties may include internal auditing and participation in computer system validations.

Qualifications

  • Minimum 5 years related experience required
  • Minimum Bachelors degree or certification required
  • Equivalent combination of Associates degree and 5 – 7 years of related experience

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