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.
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
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
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.