QA Reviewer - Eurofins BioPharma Product Testing Toronto, Inc.

Job description

This position is responsible for ensuring compliance with applicable regulations (i.e. ISO 17025, GMP, GLP), for clients requiring quality assurance services. 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 Key Skills, Experience & Abilities: Knowledge of ISO 17025 and GMP requirements GMP experience will be an added asset 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 Education: Degree or diploma in a science-related discipline Computer proficiency in Microsoft Office, especially Excel Working Conditions: This position will be working in office and lab environments. Moderate level of activity and some light lifting requirements to fulfill any required duties. Evening or weekend work may occasionally be required.