Specialist I, Quality Assurance
2 weeks ago
SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Job Description
Specialist I, Quality Assurance is responsible for assisting management with the maintenance of the Quality Systems at SGS. The Quality Assurance 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.
- Provides support to technical staff in their efforts to ensure that routine testing submitted by clients is completed within established parameters governing turnaround time, quality specifications, etc.
- Ensure that all customer requests for information pertaining to SGS services are met in a timely and effective manner.
- Issues Certificate of Analysis in a timely manner
- Review and approval of method transfer and validation reports
- Play a role in departmental or company wide projects designed to improve the internal efficiency and overall quality of work performed at the lab.
- Participate in creating and maintaining an atmosphere of teamwork throughout the lab.
- Provide support in the maintenance of Quality Assurance processes, such as OOS investigations, deviation reporting, vendor approval, internal audits, trending, and other quality systems as directed by management
- Technical responsibilities may include reviewing online audit trail, undelete log, computerized system backup activities, assisting in monitoring list of change controls to ensure timely completion, Project binder, SOP maintenance, and other support activities within QA and CVS group.
- Maintain Thorough Knowledge and understanding of all general SOPs pertaining to the lab.
- Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work perform in the laboratory.
- May participate in the preparation and review process of the appropriate department SOPs, worksheets and data forms
Qualifications
- B.S. in Chemistry, Biology, Microbiology, or related science field
- 0-2 years of experience preferably in Life Sciences supporting cGMP Operations
- Thorough knowledge of scientific principles is required
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