Specialist I, Quality Assurance

SGS•Fairfield, NJ

About The Position

The Specialist I, Quality Assurance assists management with maintaining SGS Quality Systems in a pharmaceutical testing laboratory. Assignments are generally provided by a Team Leader or Manager. The role requires sensitivity to demanding regulatory compliance requirements and a strong commitment to interpersonal relations. The specialist supports technical staff in completing client routine testing within established turnaround times and quality specifications, performs routine testing for client-specific projects, and approves and issues Certificates of Analysis and signs cGMP-related reports. The position also contributes to client-service improvement projects, staff training, equipment maintenance and calibration, and compliance with applicable SOPs for records, documentation, and customer complaints.

Requirements

  • Bachelor of Science in Chemistry, Biology, or Microbiology, or equivalent experience.
  • Thorough knowledge of scientific principles.
  • Ability to perform each essential duty satisfactorily, with or without reasonable accommodations.

Nice To Haves

  • 0–2 years of experience, preferably in Life Sciences supporting cGMP operations.

Responsibilities

  • Assist management with maintaining the Quality Systems at SGS.
  • Support technical staff in completing routine client testing within established turnaround-time and quality parameters.
  • Perform routine testing in conjunction with client-specific projects.
  • Approve and issue Certificates of Analysis and sign cGMP-related reports.
  • Participate in departmental and company-wide projects to improve client services.
  • Train on applicable general SOPs pertaining to the Analytical Laboratory.
  • Participate in general staff training sessions as scheduled.
  • Participate in departmental equipment maintenance and calibration efforts.
  • Adhere to SGS SOPs governing official records and documentation.
  • Comply with applicable SOPs related to handling customer complaints.

Benefits

  • Medical, dental, and vision insurance.
  • Life insurance.
  • Employee wellness programs.
  • Competitive pay.
  • 401(k) with company match and immediate vesting upon enrollment.
  • Employee referral program.
  • Annual bonus target.
  • Online training courses and virtual and classroom development experiences.
  • Tuition reimbursement program.
  • Paid time off, including vacation, sick time, company holidays, floating holidays, and volunteer time.
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