Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Quality Control Specialist

Job Code: #796
Job Type: Contract To Hire
Salary: $22.69 - $26.00/hour
Job Location: Lincolnshire, IL
Posted 4 days ago

Job Description

Job Title:  Quality Control Analyst 

Pay:  $22.69 - $28.00

Shift: 
2nd (2:00pm - 11:00pm)

Job Overview:  The Quality Control Specialist is responsible for the second person review of selected data generated in the laboratory. Assignments are generally overseen by a Team Leader. The Quality Control Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations.
  • Perform data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include wet chemistry, instrumentation and/or microbiological data reviews.
  • Perform reviews for reagent and standard preparations and their assays or suitability testing and/or media preparation and associated media checks. Perform equipment performance logs review, auxiliary log book reviews, stability study pull reviews, audit trail reviews and metrology reviews.
  • Perform special project data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include wet chemistry, instrumentation and/or microbiological data reviews.
  • Perform Out of Specification (OOS) and Method Validation Failure (MVF) wet chemistry and/or microbiology investigations following staff performance of customer test requests in a timely and effective manner.
  • Ensure that all testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications.
  • Ensure that all reasonable requests from Department Management pertaining to review of laboratory data supporting a given test or group of tests are met in a timely and effective manner.
  • Play a role in Departmental or company-wide projects designed to improve the internal efficiency
    and overall quality of work performed at the laboratory.
  • Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory.
  • Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs)
    pertaining to the review process.
    Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory.
  • May be invited to participate in the preparation and review process for appropriate department SOPs, worksheets and data forms.
Requirements:  
  • B.S. in Chemistry, Biology, Microbiology or equivalent experience required.
  • Thorough knowledge of scientific principles required.
  • Job requires mobile use of hands and arms. Reasonable accommodations will be made for persons
  • with disabilities.
  • Must be capable of working at a desk and computer terminal for up to three hours at a time, and for up to eight hours on a given day.
  • Familiarity with all of the laboratory techniques and equipment applicable to the tasks performed in
  • the laboratory.
  • Highest commitment to GMPs with regard to the recording of laboratory data for testing of
  • pharmaceuticals and medical devices.
  • Excellent language and communication skills required.
  • Must be able to clearly communicate responsibilities of solid documentation needs on a daily basis.
  • Good listening skills are essential.
  • Must be able to work with a diverse group of individuals.