QA Reviewer - Eurofins BioPharma Product Testing Toronto, Inc.

Eurofins•Toronto, ON

7d•CA$50,000 - CA$50,000•Hybrid

About The Position

This position is responsible for ensuring compliance with applicable regulations (i.e. ISO 17025, GMP, GLP), for clients requiring quality assurance services.

Requirements

Knowledge of ISO 17025 and GMP requirements
Must speak and write English fluently
Must possess excellent communication skills, both written and verbal
Must be articulate
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
Exceptional computer skills with a high level of competence with MS Office (Outlook, Word, Excel)
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
Degree or diploma in a science-related discipline
Computer proficiency in Microsoft Office, especially Excel

Nice To Haves

GMP experience will be an added asset

Responsibilities

Review and determine the status of the quality documents (including, but not limited to, raw laboratory data, validation studies, logbooks, and calibration reports)
Providing support with maintaining Quality System, including drafting and updating quality procedures
Assisting with internal and external audits
Ensuring that all reports and accompanying raw data are according to GMP and ISO 17025, accurate, correct and acceptable according to the study protocol, methods and relevant SOPs
Interacting with department staff to acquire information for report writing and auditing purposes and present information to staff regarding deficiencies and areas of improvement
Log and review complaints; compile required ISO 17025/ GMP documents for the evaluation of complaints
Perform and manage the internal auditing program if required
Manage the ongoing tracking and maintenance of GMP and ISO 17025 documents
Support the training of new staff
Evaluate and summarize instrumentation data in final reports
General record-keeping practices according to local and global SOPs
Review training records and generate associated reports if required
Initiate and conduct deviations and out-of-specification investigations
Initiate and conduct Corrective Action and Preventative Action (CAPA) investigations
Initiate and assist in Change Control procedures
Adhere to the Standard Operating Procedures
Circulate Standard Operating Procedures and follow up on training requirements
Ensure that all staff members are following the Standard Operating Procedures at all times
Assist with the maintenance of ISO 17025 and GMP accreditation
Attend staff meetings
Any other duties as delegated by the Department Head or designated