Biotech Document Reviewer (1 Year Contract)

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 improvment 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.
• Audits calibration related documents and other QC documents;
• Inputs data for trending departmental KPIs;

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
• Works well under pressure.
• Extended hours or weekend work may be required from time to time.
• Shift work may be required
• Ability to learn quickly in a challenging environment.
• Excellent language, writing and communication skills required.