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.
The Quality Control Specialist 1 in the Quality Control Unit at SGS Life Science Services reports to the designated Operations Management.
SPECIFIC RESPONSIBILITIES 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. • Ensure that all customer requests for information pertaining to testing (or any other services) are met in a timely and effective manner. • Ensure that routine testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications. • Ensure that data recorded attendant to customer requests pertaining to the development and completion of specialized studies is reviewed in a timely and effective manner.
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 general SOPs pertaining to the laboratory. • 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.
EXPERIENCE/EDUCATION • 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 performing bench testing. • Must have a solid grasp of the fundamentals and importance of teamwork in the contemporary business world.
OTHER INFORMATION: • Safety is a top priority within SGS. Every employee within the organization has defined HSE Duties and Responsibilities to ensure that the organization meets its objectives of no harm to personnel, damage to equipment, or harm to the environment. • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability 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. • SGS is an Equal Opportunity Employer.
ADDITIONAL INFORMATION • 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, skill, and/or ability 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. • SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
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