Quality Assurance Document Reviewer - Eurofins Experchem Laboratories, Inc.

at  Eurofins Canada Food testing

IN 2023, EUROFINS GENERATED TOTAL REVENUES OF EUR 6.515 BILLION, AND HAS BEEN AMONG THE BEST PERFORMING STOCKS IN EUROPE OVER THE PAST 20 YEARS.

Job Description
The Quality Assurance Document Reviewer is responsible for ensuring compliance with applicable regulations (i.e., ISO17025, GMP, GLP), for clients requiring quality assurance services.

KEY SKILLS & ABILITIES

• Must possess excellent communication skills, both written and verbal;
• Excellent organizational skills;
• High level of accuracy and strong attention to detail;
• Ability to work independently, while supporting a collaborative, team-based department;
• Ability to multitask and remain calm under pressure;
• High level of professionalism, maturity, good judgement, and discretion when dealing in confidential matters;
• Must be proactive, self-disciplined and able to demonstrate a high level of productivity;
• Demonstrate satisfactory work performance and attendance record;
• Willingness to learn with the ability to retain information quickly and apply knowledge to various scenarios;
• Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel);
• Previous experience in QA is essential.
  Qualifications

BASIC MINIMUM QUALIFICATIONS:

• 1-5 years of progressive quality experience in a GMP environment is required;
• Knowledge of GMP Health Canada data integrity requirements;
• Minimum of 5 years of laboratory experience (R&D and/or QC);
• Must speak and write English Fluently;
• Authorization to work in Canada.

EDUCATION

• Bachelor of Science or Diploma is science related discipline

• Perform data review and approval of method validation, method verification and method transfer projects as well as organize final validation packages for clients;
• Review and approve calibration and preventative maintenance data as required;
• Prepare, review and approve Instrument/Equipment Qualification protocols and reports;
• Perform data review of projects carried out in the laboratory;
• Ensure corrections are completed in a timely manner and data is released promptly as required;
• Ensure the appropriate analyses are conducted, proper methods are followed and if applicable, method modifications are applied and followed;
• Liaise with other departments to ensure proper method, specification, protocol and results;
• Verify that all results reported are within specification, notifying of any OOS;
• Display proper judgment during investigations;
• Designate in lieu of Supervisor to send results to client;
• Troubleshoot and respond quickly when problems arise;
• Ensure adherence to SOPs and compliance with GMP;
• Apply and follow data integrity procedures;
• Any other duties as requested by supervisor.