KIK Custom Products

QC Microbiologist

US-IN-Elkhart
2 weeks ago
Job ID
2017-4722
# of Openings
1
Division
KCM

Overview

Custom New Logo

 

Perform Microbiological testing per specifications, utilizing internal SOP’s, GMP’s and current validated methods for testing of raw materials and finished products to ensure that microbiological quality and product integrity is maintained.

Essential Job Functions

  • Performs all required microbiological analysis on raw materials, pretreatment water, purified water, bulk batches and finished products.
  • Maintains required cultures and prepare and maintain necessary media. This is to be done via manufacturer’s instructions. Perform sterility control and growth promotion tests.
  • Tests the efficacy of preservation on products utilizing a variety of tests and maintains all records as required.
  • Conducts site micro awareness training. May also train Compounders and Warehouse on proper sampling technique.
  • Conducts auditing to ensure GMP practices are followed, and if required simulates FDA Inspections.
  • Maintains accurate logbooks and complete documentation as required.
  • Report and investigate out of specifications (OOS) results. Determine root cause and implement corrective action.
  • Participates in project teams and performs duties as assigned.
  • Collect Micro Daily Management (MDM) samples at appropriate intervals.  Analyze MDM data for trending and establish microbial profile of indigenous flora of facility.
  • Performs microbiological test method suitabilities as needed.
  • Executes validation protocols as it pertains to microbiological sampling.

 

The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.

Qualifications

Bachelor degree (or higher) required in area of discipline

 

 

 

Thank you for your interest and consideration of a career with KIK!

KIK is an Equal Opportunity / Affirmative Action employer.  Qualified applicants will receive consideration for employment without regards to race, color, religion, sex, or national origin.

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