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.