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Quality Manager

Edison-New Brunswick Metro Area, NJ

Posted: 05/20/2019 Job Type: Scientific Job Number: JN -052019-24914
Duties:
  • Experience managing client/vendor relationships
  • Required knowledge of manufacturing/packaging operations; including environmental monitoring, drug product manufacturing/packaging, product shipping, ancillary systems/utilities (i.e. HVAC, water, compressed gases), stabilitytesting and release testing
  • Experience supporting cross-functional project teams
  • Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed
  • Experience dealing with external supply world, contract manufacturing
  • Product knowledge of Non Sterile Products- tablets, capsules, ointments/creams, etc.
  • Experience in TrackWise based system or similar systems- customer complaints, deviations, etc.
  • Strong Communication Skills both oral and written- Savy in electronic systems as well

Skills:
  • Requires knowledge of Quality Systems, FDA GxP regulations and guidance for pharmaceutical manufacturing.
  • Requires excellent verbal/written communication, negotiation/influencing, leadership and risk assessment skills.
  • Ability to author quality agreements with contract development, manufacturing, and laboratory organizations.
  • Understands quality by design principles and how to define critical process parameters.
  • Can conduct FMEA to assess risk and identify risk mitigation actions
  • Complete Annual Product Quality Reports (APQR)
  • Review statistical analysis that measures process capability and trending performance.
  • Experience in negotiation/influencing and management of remote third party partners
  • Ability to work independently on problems and issues and determine acceptable solutions and approaches
  • Requires strong computer skills in MS Word, Excel, PowerPoint, Adobe Acrobat, Trackwise, SAP, and the ability to learn/execute data entry into various databases
  • Awareness of standard health, safety and environmental requirements in pharmaceutical manufacturing

Education:
  • B.S. Degree in Engineering or Science or equivalent with a minimum of 5 years pharmaceutical industry experience (may include Operational/Quality/Compliance/Validation experience in pharmaceutical industry).

Required:
  • Experience in managing client/vendor relationships
  • Required knowledge of manufacturing/packaging operations in the pharmaceutical industry
  • Experience supporting cross-functional project teams
  • Ability to troubleshoot manufacturing/packaging process deviations and analytical OOS results as needed.
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