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Manager, Blood Products, Reagents and Manufacturing (5875)
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Manager, Blood Products, Reagents and Manufacturing (5875)

Job Description


Manager, Blood Products, Reagents and Manufacturing (5875)

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Follow us: @JournalSentinel on TwitterProvide direct leadership to the manufacturing staff and supervise all activities of the department.  

Duties:

  • Reviews test results and all device history records of reagent manufacturing staff for conformance to SOPs and specifications
  • Assist in development of departmental staff performance objectives, competency evaluations and appraisals
  • Responsible for the training of new manufacturing employees and maintenance of all department files
  • Assist with validation studies, product and process improvement projects
  • Prepare necessary department protocols, procedures and processes for new products, or processes including validation activities and stability assessments

Job Requirements


Manager, Blood Products, Reagents and Manufacturing (5875)

  • Must have thorough understanding of GMP, FDA, and ISO 13485 requirements for the manufactureing of in vitro Diagnostic Devices
  • Maintain departmental inventory (chemical, raw materials, components) and schedule raw materials  and schedule other production supply purchases to maintain inventory requirements
  • Bachelors Degree required
  • MLT (ASCP) licensure preferred
  • Minimum of 3 years in a managerial role in medical device, pharmaceutical or biotech arena
  • Compensation: Competitive compensation
  • Miscellaneous Information: cGMP, FDA, ISO 13485, in vitro disgnostic devices, blood grouping reagents

Job Snapshot

Employment Type Full-Time
Job Type Health Care, Biotech
Education 4 Year Degree
Experience At least 3 year(s)
Manages Others Yes
Relocation Yes
Industry Healthcare - Health Services
Required Travel Negligible
Job ID 5875
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Manager, Blood Products, Reagents and Manufacturing (5875)


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