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Document Reviewer Level 1

Document Reviewer Level 1

SGSMarkham, ON, CA
21 days ago
Job type
  • Full-time
Job description

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 reviewes that all results are entered into the electronic laboratory information system LIMS.

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.
  • Comfortable with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records
  • Shift work may be required
  • Ability to learn quickly in a challenging environment.
  • Excellent language, writing and communication skills required.