Quality Control Specialist I
SGS North America
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 than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.
The Quality Control Specialist I 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 I 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.
Reports to the Quality Control Supervisor, Quality Control Team Leader or Department Manager.
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 biology and instrumentation 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 biology and instrumentation data reviews.
• Perform Out of Specification (OOS) and Method Validation Failure (MVF) biology 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.
• 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.
• 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.
• B.S. in Biology 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.
• Must have a solid grasp of the fundamentals and importance of teamwork in the contemporary business world.
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.
o 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 call back. 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
All your information will be kept confidential according to EEO guidelines.