Documentation Reviewer - Level 1

About the Company

SGS is a globally recognized leader in testing, inspection, and certification. The company is known as a standard-setter for sustainability, quality, and integrity, with a large international workforce operating across a worldwide network of offices and laboratories.

Role Overview

This position is responsible for reviewing and approving data through document review in a prompt, accurate, and compliant manner. The work must align with approved methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP), and standard operating procedures (SOPs) used within SGS Life Science Services Analytical Laboratories and related departments. Training must also follow the designated training SOP and associated training record requirements.

Key Duties

• Check QC records to confirm they meet the relevant methods, protocols, specifications, and SOP requirements.
• Contribute to improving SGS SOPs, analytical methods, protocols, and forms when issues or gaps are identified.
• Complete assigned reviews by the deadlines shown on lab sheets or set by a supervisor.
• Provide dependable quality and regulatory guidance on unusual or non-routine matters.
• Verify that validation, method transfer, and verification records and reports match the client-provided protocol or SGS-written method.
• Ensure any OOS results or deviations are resolved before records are sent to QA for release of the Certificate of Analysis.
• Confirm that results are reported correctly on either a Certificate of Analysis or a Report of Analysis, depending on the validation or transfer status of the method.
• Review data within required timelines and approve records before the due date.
• Review method development records in accordance with SGS SOPs.
• Prepare an audit form when deficiencies are found in methods or procedures, return it to the analyst for correction under the Data Review SOP, and make sure all valid issues are corrected; escalate unresolved concerns to management.
• Notify the analyst or the analyst’s supervisor to start an out-of-specification process if an OOS issue was missed by the analyst.
• Oversee OOS investigations according to SGS SOPs, provide input to the investigator, and review investigations in line with regulatory expectations.
• Audit all related record books and log books tied to the testing that has been reviewed and approved.
• Maintain documented and approved trainer status for the areas the employee is qualified to train.

Qualifications

The role calls for a Bachelor of Science degree, or an equivalent mix of education and experience. A College background may also be acceptable when paired with 10 years of pharmaceutical QC testing and records review experience. Suitable fields include Chemistry, Biochemistry, Biology, Microbiology, or another related biological science.

Experience

Applicants should bring more than 5 years of experience in a regulated pharmaceutical laboratory environment or with a pharmaceutical company.

Additional Information

The posted pay rate is $25.00 to $31.00 per hour.

Benefits

• Health, dental, and vision coverage at 80%
• Paid time off
• Eligibility for the RRSP program

Equal Opportunity and Accommodation

SGS Canada is an equal opportunity employer and supports accessibility throughout the hiring process. Accommodation is available on request for qualified candidates at every stage of recruitment.

Work Authorization

Applicants for Canadian roles must be authorized to work in Canada.