Biotech Document Reviewer

SGS

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Company Description

WE ARE SGS – THE WORLD’S LEADING TESTING, INSPECTION AND CERTIFICATION COMPANY. WE ARE RECOGNIZED AS THE GLOBAL BENCHMARK FOR QUALITY AND INTEGRITY. OUR 89,000 EMPLOYEES OPERATE A NETWORK OF 2,600 OFFICES AND LABORATORIES, WORKING TOGETHER TO ENABLE A BETTER, SAFER AND MORE INTERCONNECTED WORLD.

Job Description

  • Assures that reviewed QC records are compliant to methods, specifications and company’s applicable Standard Operating Procedures.
  • The review is done according to QAM-210 Data Review SOP
  • Identifies area for improvement of SGS SOPs, analytical methods and forms.
  • Follows deadlines specified on a lab sheet or as scheduled by their supervisor.
  • Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS
  • Assures that OOS and deviation are closed before forwarding the records to QA for release of C of A.
  • Issues an audit form noting deficiencies to method and procedures, returns the form to analyst for correction according to Data Review SOP; Ensures that all valid deficiencies are corrected; escalates all concerns to management.
  • Ensures that documentation review is complete in every respect and reviews that all results are entered into the electronic laboratory information system LIMS.
  • Audits calibration related documents and other QC documents;

Qualifications

  • Education: Bachelor of Science degree (or equivalent combination of education and experience such as College with 10 years of pharmaceutical QC testing/records review experience) in Chemistry, Biochemistry, Biology, Microbiology or related biological science or equivalent in job experience
  • Experience: over 2 years’ experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical company.
  • Previous experience with molecular biology and electrophoresis techniques (ie western blot/SDS-PAGE)
  • Comfortable with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records
  • Extended hours, shift work or weekend work may be required from time to time.
  • Ability to learn quickly in a challenging environment.
  • Excellent language, writing and communication skills required.

Additional Information

SGS Canada is an equal opportunity employer and we are committed to achieving greater accessibility by providing accommodation for people with disabilities during our hiring process. Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada.

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