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90286 Requisition #
Thanks for your interest in the Manager Quality Control position. Unfortunately this position has been closed but you can search our 933 open jobs by clicking here.

DESIRED QUALIFICATIONS:

 

 

EDUCATION & EXPERIENCE (REQUIRED):

 

Bachelor’s degree in related scientific field and 6 years relevant experience; or Master’s degree and four years of related experience or an equivalent combination of education and experience.

 

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

  • Ability to manage a team of QC Analysts working on clinical stage product release in a dynamic environment
  • Be an SME for Microbiological assays, Environmental Monitoring and EM trending program.  Represent QC during audits as an SME for QC operations. 
  • Extensive technical QC experience in clinical laboratory, hematology, blood banking, immunology or QC laboratory preferably in cGMP environment.
  • Experience with performing laboratory investigations related unexpected results (Out Of Specification) and deviations and writing relevant investigation reports.  Experience with lean/six sigma principle and implementing sustainable CA/Pas is a plus.   
  • Extensive experience in Microbiological assays, compendial test methods and verification/qualification of such methods.  Experience with cell/molecular based assays related to cell and gene therapies (Flow Cytometry, qPCR, ddPCR, CFU, etc.) is highly desired.
  • Demonstrated resolution of complex issues in creative and effective ways
  • Excellent organizational skills and attention to detail.

 

CERTIFICATIONS & LICENSES:

 

None

 

PHYSICAL REQUIREMENTS*:

 

  • Frequently sit, grasp lightly, use fine hand manipulation, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of the job.

Additional PHYSICAL REQUIREMENTS: (remove if none)

WORKING CONDITIONS:

 

  • May require working in close proximity to blood borne pathogens.
  • Position may at times require the employee to work with or be in areas where hazardous materials and/or infectious diseases are present.
  • Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, protective clothing and gloves, and possibly a respirator.
  • May require extended or unusual work hours based on research requirements and business needs.
  • May be exposed to high voltage electricity, radiation or electromagnetic fields, lasers, noise > 80dB TWA, Allergens/Biohazards/Chemicals, confined spaces, working at heights

May require occasional local and overnight travel

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