Documentation Reviewer - Level 1

Job Description

Performs review and approval of data based on document review in a timely and effective manner according to methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs) of SGS Life Science Services Analytical Laboratories and Departments. Follow Training SOP for training and training records.

• Assures that reviewed QC records are compliant to methods, protocols, specifications and company’s applicable Standard Operating Procedures. 
• Identifies, and Leads the improvement of SGS SOPs, analytical methods, protocols and forms. 
• Follows deadlines specified on a lab sheet or as scheduled by their supervisor.  
• Consistently able to provide industry quality and regulatory guidance on non-routine matters, 
• 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. 
• Ensures test results are reported appropriately on either a C of A or a R of A depending on the validation/transfer status of the method. 
• Assures review of data in a timely manner and approval of records prior due date. 
• Assures method development records are reviewed as per SGS SOPs; 
• 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.
• Informs analyst or his/her supervisor to initiate out -of-specification and/or issue OOS form in case of OOS, which was not noted by analyst; 
• Assures OOS investigations are performed according to SGS SOP. Consults to OOS investigator, and reviews OOS investigations according to SGS SOP and regulatory requirements. 
• Audits all record books (log-books) associated with testing reviewed / approved; 
• Has and maintains documented, approved Qualified Trainer record for the aspects he/she trains others.

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 5 years’ experience working in a pharmaceutical regulated Laboratory environment or pharmaceutical company.

Additional Information

Salary: $25.00 - $31.00/Hour

Some Benefit Highlights:

• 80% coverage Health, Dental and Vision 
• Paid time off
• RRSP Program Eligibility 

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