Quality Assurance Specialist I
SGS North America Inc.

Fairfield, New Jersey


Company Description

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 than94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

The Quality Assurance Specialist 1 is responsible for assisting management with the maintenance of the Quality Systems at SGS. Assignments are generally provided by a Team Leader or Manager. The Quality Assurance 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.

REPORTING LINE

The Quality Assurance Specialist 1 in the Quality Assurance Unit at SGS Life Science Services reports to Quality Assurance Management.

SPECIFIC RESPONSIBILITIES

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

• Ensure that all customer requests for information pertaining to SGS services are met in a timely and effective manner.
• Help in the documentation and resolution of customer complaints.
• Issue Certificate of Analyses in a timely manner
• Review and approval of method transfer and validation reports
• Host customer audits of the laboratory

SERVICE RESPONSIBILITIES TO INTERNAL CUSTOMERS
.
• 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.
• 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 Quality management.
TECHNICAL RESPONSIBILITIES

• This may include reviewing online audit trail, undelete log, computerized systems backup activities, assist in monitoring list of change controls to ensure timely completion, Project Binder, SOP maintenance and other support activities within QA and CSV group.
• 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.
• Compliance with applicable SOPs related to the handling of customer complaints.
• Adherence to applicable personnel policies regarding time clock, telephones, sick days, vacation days, etc.
• Participation in general staff training sessions as these are scheduled.
• Approve and issue Certificate of Analysis and sign on cGMP related reports.

Qualifications

• Associate or B.S. in Chemistry, Biology, Microbiology or equivalent experience required.
• 0-2 years of experience preferably in Life Sciences and/or IT supporting cGMP Operations.
• 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

• 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.


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