Quality Control


Job Number:    #1223
Location:   Mountain Time Zone   (relocation assistance provided)


POSITION SUMMARY                                 (New Position)


Essential Duties & Responsibilities

  • Will be responsible for the establishment and expansion of the quality control/microbiology function at this facility

  • Validation, qualification, and transfer of analytical methods into the QC department

  • Oversee stability program, including onboarding of new programs, in accordance with ICH requirements

  • Responsible for release of raw material, production support, finished product, and stability samples

  •  Author and review laboratory investigation reports, deviations, and technical documents

  • Perform forecasting for resource and stability needs

  • Propose and oversee implementation and validation of new equipment

  • Interface with investigators during client audits and regulatory inspections

  • Provide pricing estimates for established and potential clients

  • Perform trending of analytical method performance and results

  • Oversee and execute continuous improvement

  • Represent all QC functions (Incoming, Microbiology, Chemistry) as the department representative in client project meetings

  • Support QC Metrology and LIMS activities

Education & Experience

  • BS Degree - Scientific, Engineering, Technical related – MS a plus

  • 15+ years experience in pharmaceutical quality control management. 

  • Sterile Pharmaceutical Manufacturing experience will be a plus

  • Excellent problem solving and communications skills





LINKS TO OTHER JOB DESCRIPTIONS (at this same start-up Facility):

Information - This Hiring Project


Quality Assurance - Director/Head

Engineering - Director/Head

Plant Manager


Should you elect to send your resume to us, we will never forward it to anyone without first contacting you and receiving your approval to do so.


NOTE:   This is an unofficial document prepared by S L Collins Associates, Inc. to provide basic information concerning the position.   The company we are conducting this search for has the official job description.


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