Job Description

Specialist I, Quality Control is responsible for the second person review of selected data generated in the laboratory. The Quality Control Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to the SGS customer base.

• 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 reviews for reagent and standard preparations and their assays or suitability testing and/or media preparation and associated media checks
• Perform equipment performance logs reviews, auxiliary log book reviews, stability study pull reviews, audit trail reviews, and metrology 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 on the 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
• Participate in creating and maintaining an atmosphere of teamwork throughout the laboratory
• Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs) of 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
• Participation in general staff training sessions as is scheduled

Qualifications

• Bachelor of Science in Chemistry, Biology, Microbiology, or equivalent.
• Thorough knowledge of scientific principles.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a callback. Please note, this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.