Pharmaceutical (QA) Batch Record Review

Devens, Massachusetts
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Type: Contract

Category: Scientific & Clinical

Job ID: 152231

Date Posted: 06/29/2020


Quality Associate Batch Record Review

Must haves:

  • BS in a scientific discipline or equivalent with a minimum 3-5 years’
  • MS in a scientific discipline or equivalent with a minimum of 1-3 years’ experience
  • Experience working in an FDA regulated industry
  • Rreally would prefer someone with experience with batch records, CAPA’s, QC data review in a GMP environment).
  • Experience with Quality Assurance oversight and support for all phases of clinical trials.
  • Experience with Microsoft Office and other complex computer software
  • Experience with commercial phase pharmaceuticals
  • EMEA experience

 

Responsibilities

 

  • Perform review and release of Regulatory Starting Materials, Intermediates and Active Pharmaceutical Ingredients (APIs)
  • Support of clinical and commercial product manufacturing.
  • Assist in the development, implementation, and maintenance of quality systems, related
  • Review and approve master and executed batch records, deviations, OOS/OOT investigations, test method qualifications and validations, stability and Quality Control data and reports compliance to internal and GMP standards.
  • Identify issues that may impact products or failures to comply with local or regulatory
  • Represent the department during project meetings, client audits and FDA inspections, if needed.
  • Write and revise Standard Operating Procedures (SOPs) as required.
  • Review master documents such as In-process forms and Batch Records.

 


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