Biotech Document Reviewer

2 weeks ago

Mississauga, Canada SGS Full time

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.

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