Specialist I, Quality Assurance

2 months ago


Stamford, Connecticut, United States SGS North America Inc. Full time
Company Description

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
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 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.

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