QA Data Reviewer - Eurofins BioPharma Product Testing Toronto, Inc
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- Toronto, ON
- 50.000 $ par an
- Permanent
- Temps-plein
- Perform data review of batches carried out in laboratory, including raw data review and calculations;
- Perform data review of method validation and method transfer projects as well as organize final validation packages for clients;
- Perform data review of local Method Development and/or Verification Reports;
- Prepare/Review/Check Instrument/Equipment Qualification protocols and reports;
- Review and approve calibrations and preventative maintenance;
- Ensure GMP compliance;
- Apply and follow the data integrity procedures;
- Ensure reports follow designated SOPs and comply with GMP;
- Ensure corrections are completed in a timely manner and released promptly as required;
- Ensure appropriate analyses conducted and proper method followed, and method modifications are applied and followed;
- Verify that all results reported are within specification;
- Display proper judgment during investigations;
- Troubleshoot and respond quickly when problems arise;
- Any other duties assigned by Supervisor.
- Bachelor of Science in Chemistry, Microbiology, Food Science or Life Science;
- Minimum 3 years of GMP experience reviewing chemical analytical reports is required;
- Hands-on experience reviewing HPLC, GC, UV, and wet chemistry data;
- Knowledge of GMP requirements;
- Must speak and write English fluently;
- Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel);
- 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 judgment, 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.
- Previous experience in QA is essential.
- 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.
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