QA Reviewer - Eurofins Biopharma Product Testing Toronto, Inc.

QA Reviewer - Eurofins BioPharma Product Testing Toronto, Inc.

Eurofins BioPharma Product Testing Toronto, Inc. is seeking a detail-oriented and analytical QA Reviewer to join our team in Toronto, Canada. In this critical role, you will be responsible for ensuring compliance with applicable regulations and maintaining the highest quality standards in our biopharmaceutical testing processes.

Responsibilities include:

• Review of all analytical data/documents related with R&D and QC testing, e.g.: method validation, method verification, method transfer, finished products, bulk, raw material and stability study products as per GMP requirements.
• Prepare and review protocol, report and test method for method validation, method verification, method transfer study.
• Review all raw data and chromatograms using different software (e.g. Empower, Chromeleon, Mass Hunter, Analyst software etc.) and then release report/COA on e-LIMS.
• Train junior analysts in method validation, method verification and method transfer study including related software usage (Empower, ETQ, Chromeleon, other software associated with LC-MS/MS. GC-MS/MS, ICP-MS/OES).
• To ensure data integrity is maintained in all the process.
• Participate in and/or lead out of specifications investigations OOS.
• Initiate CCR and complete Corrective and Preventive Actions (CAPA's).
• Participate in Internal, Customer and Regulatory Audits.
• Assist laboratory personnel with documentation issues and provides coaching and guidance to R&D team.
• Perform analysis using different instruments (e.g. HPLC, GC, LCMSMS, GCMSMS, UV-Vis, FTIR) and wet Chemistry techniques.
• Provide technical support to clients in relation to R&D, Validation and Technology Transfer.
• Troubleshoot technical issues/ difficulties with methods.
• Archive all GMP documents related with raw data, test method, protocol & report.
• May be essential to perform work in weekend, after hours and rotating shift work (as required).
• Follows up with analysts/technicians to ensure that all necessary corrections are corrected in accordance with Good Manufacturing Practices standards.
• Audits calibration related documents and other R&D /QC documents;
• All other jobs assigned by Department Head of R&D.
• Review and determine the status of quality documents, including raw laboratory data, validation studies, logbooks, and calibration reports
• Provide support in maintaining the Quality System, including drafting and updating quality procedures
• Assist with internal and external audits to ensure compliance with GMP and ISO 17025 standards
• Review and verify the accuracy of reports and accompanying raw data according to study protocols, methods, and relevant SOPs
• Interact with department staff to gather information for report writing and auditing purposes
• Log and review complaints, compiling required ISO 17025 and GMP documents for evaluation
• Manage the internal auditing program and ongoing tracking of GMP and ISO 17025 documents
• Support the training of new staff and review training records
• Assist in maintaining ISO 17025 and GMP accreditation
• Collaborate with cross-functional teams to ensure consistent quality standards across the organization

Qualifications include:

• Bachelor's degree or diploma in a science-related discipline
• Over 3 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company.
• Ability to work with electronic systems and other lab equipment to be able to perform audit trail of testing records.
• Knowledge of GC, HPLC, UV, IR, LC-MS/MS. GC-MS/MS, ICP-MS/OES and other analytical instrument.
• Sound knowledge of Health Canada and FDA regulations.
• Comprehensive knowledge of ISO 17025 and GMP requirements
• GMP experience in the biopharmaceutical industry preferred
• Strong understanding of quality assurance processes and regulatory compliance in the pharmaceutical industry
• Excellent written and verbal communication skills
• Exceptional organizational abilities with a high level of accuracy and attention to detail
• Proficiency in MS Office suite, particularly Excel, Word, and Outlook
• Experience in quality document review and auditing
• Familiarity with corrective and preventive action (CAPA) processes
• Ability to multitask and remain calm under pressure
• Strong analytical skills with the ability to interpret and summarize complex data
• Collaborative mindset with the ability to work independently and as part of a team
• Customer-focused approach with a commitment to meeting quality standards
• Willingness to learn and adapt to new processes and technologies

Working conditions include:

• This position will be working in a laboratory environment where standing is required for greater than 50% of the time. Light lifting requirements of no more than 30 lbs. Hazardous materials are handled using established safety procedures and appropriate PPE.
• Shift work and overtime may be required, as well as working periodic weekends and/or evenings.

Additional benefits include:

• Excellent full-time benefits including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, paid time off.
• Accommodation: Persons with disabilities who need accommodation in the application process, or those needing job postings in an alternative format, may e-mail a request via the website at www.eurofins.ca.
• As a Eurofins employee, you will become part of a company that has received international recognition as a great place to work. To learn more about Eurofins, please explore our website at www.eurofins.ca.
• We thank all applicants within commuting distance of GTA, Ontario for showing an interest in this position. Only those selected for an interview will be contacted.
• This posting is supported by AI technology to assist in screening candidates and resumes.