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Quality Manager
Pharmaceutical/Manufacturing/R&D
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Location: Raritan, NJ
Pay Rate: Contract: 40.22 to 56.04 $/hr
Salary: 83.66 to 116.56 K$/yr
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Position Type/ Job Duration: Contract 6 - 12 months
Education Required: BS 
Years Experience Required: 5

Industry:
Healthcare
Job Posted: 10/19/2017
Should I worry about this date?
Apply Deadline: 11/20/2017
Job #: 133529HHM
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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A leader in pharmaceutical manufacturing is currently seeking a Quality Manager that is located in the Raritan, NJ, Titusville, NJ or Spring House, PA area (or remote locally to the work location in PA and NJ). This is a 11-month CONTRACT position. No per diem is provided.

Responsibilities

  • Assessment of quality issues identified by R&D Business Partners and colleagues to determine if further investigation (including root cause analysis if applicable) is needed. Assignment of ownership of issues with high and medium impact in the CAPA management system to applicable functional area owner(s) to drive further investigation as applicable.
  • Collaboration with functional owners of investigations to ensure robust investigations (with root cause analyses if applicable) are conducted and documented. Perform/Ensure timely entry of all HA observations into the CAPA management system.
  • Review and approval of corrective action and effectiveness check plans as well as documentation of completion of approved commitments in the CAPA management system. Completion of records (including coordination of evidence) to document the outcome of low impact investigations in the CAPA management system.
  • Initiate notification and/or escalation of emerging and significant risks to the Director, Self-identified CAPA Lead, and/or the relevant senior management and governance bodies, as appropriate. Support generation of periodic and ad hoc status reports on self-identified quality issues and events for trending and report out in Quality System Management Reviews in collaboration with the Quality Management Systems team.

Requirements

  • Bachelor of Science (BSc) degree in a life science, natural science or business is preferred with a minimum of 8 or more years of previous Pharmaceutical Industry experience. A minimum of 5 years of relevant experience with increasing responsibility in an applicable compliance field and/or the equivalent time and training/experience in a related R&D area (GxP regulated discipline).

Benefits

  • Healthcare
  • 401k
 
 
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