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Quality Control Specialist 1 at SGS North America Inc.

Posted in Other 30+ days ago.

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Location: Lincolnshire, Illinois





Job Description:
Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The Quality Control Specialist 1 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 1 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.
This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to SGS customer base.
REPORTING LINE
The Quality Control Specialist 1 in the Quality Control Unit at SGS Life Science Services reports to the Quality Control Supervisor or Quality Control Team Leader.
SPECIFIC RESPONSIBILITIES
OUR PROMISE TO OUR CUSTOMERS
At all times, comply with SGS Code of Integrity and Professional Conduct, and to conduct all our testing to to the highest level of cGMP compliance.
SERVICE RESPONSIBILITIES TO CUSTOMERS
• 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
SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
• 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.
TECHNICAL RESPONSIBILITIES
• 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.
ADMINISTRATIVE RESPONSIBILITIES
• Adherence to relevant SOPs governing documentation and reporting.
• Adherence to applicable personnel policies regarding time clock, telephones, sick days, vacation days, etc.
• Participation in general staff training sessions as these are scheduled.

Qualifications

• 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.
REQUIRED SKILLS
• 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.
• Must have a solid grasp of the fundamentals and importance of teamwork in the contemporary business world.


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