Specialist I, Quality Assurance

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