The Quality Assurance Document Reviewer is responsible for ensuring compliance with applicable regulations (i.e., ISO17025, GMP, GLP), for clients requiring quality assurance services.
RESPONSIBILITIES:
- 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.
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.
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
ADDITIONAL INFORMATION:
- Shift work and extra working hours may be required as well as working weekends and/or evenings;
- This is a hybrid laboratory and office environment. Hazardous materials are handled using established safety procedures and appropriate PPE in accordance with GPP, GMP, GLP and other Health Canada regulations.
At Eurofins we offer 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.
NO AGENCIES, CALLS OR EMAILS PLEASE
