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QA Specialist - Clinical Manufacturing

Newark Metro Area, NJ

Posted: 06/19/2019 Job Type: Scientific Job Number: JN -062019-25114
This position is responsible for executing cGMP Clinical Manufacturing Operational activities that are required for the manufacture and release of clinical supplies of small molecule drug products (includes small molecule parenteral drug products).

Responsibilities will include, but are not limited to, the following:
  • Member of a dynamic and scientifically driven team dedicated to the development and optimization of robust clinical manufacturing processes for drug products.
  • Leverage basic understanding of clinical manufacturing processes to conduct post-execution GMP compliance review of the manufacturing batch record and all other required supporting/related documents.
  • With the appropriate level of supervision, responsible for support of timely closure of investigations and change management records to ensure on-time compliant supply of clinical drug product for development/commercial portfolio.
  • Compile and maintain the clinical supply batchdata base for analysis in support of process development/optimization activities.
  • Assume departmental responsibilities for assigned projects.
  • Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.

  • Degree in Chemical Engineering, Pharmaceutics, Chemistry or Material Science, or a relevant scientific discipline
  • M.S. and 2+ years of relevant experience
  • B.S. and 4+ years of relevant experience

Skills/Knowledge Desired:
  • Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
  • Strong verbal communication and technical writing skills are essential; able to communicate results and issues effectively.
  • Ability to work in a team environment with engineers, scientists, and quality assurance professionals.
  • Knowledge and demonstrated application of cGMPs during pharmaceutical development and commercial manufacturing.
  • Detail-oriented with a high degree of focus
  • Strong Computer skills with knowledge of MS Office program suite, with an emphasis in MS Word, MS Excel, MS PowerPoint.
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