Senior Quality Assurance Specialist

1 week ago

Toronto, Ontario, Canada Eurofins GSC Poland Sp. z o. o. Full time

At Eurofins, we are seeking a highly skilled Senior Quality Assurance Specialist to join our team in GTA, Ontario. This exciting opportunity will be working in office and lab environments.

About the Role

This position is responsible for ensuring compliance with applicable regulations, such as Cosmetics Regulations and Food and Drugs Act and Regulations, for clients requiring quality assurance services.

Main Responsibilities:

  • Review and determine the status of quality documents, including raw laboratory data, validation studies, logbooks, and calibration reports;
  • Provide support in maintaining our Quality System, including drafting and updating quality procedures;
  • Assist with internal and external audits;
  • Ensure that all reports and accompanying raw data are according to GMP standards, accurate, correct, and acceptable according to the study protocol, methods, and relevant SOPs;
  • Interact 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 GMP documents for the evaluation of complaints;
  • Perform and manage the internal auditing program if required;
  • Manage the ongoing tracking and maintenance of GMP 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 if required;
  • 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 always following the Standard Operating Procedures;
  • Assist with the maintenance of Health Canada and FDA accreditation;
  • Attend staff meetings;
  • Any other duties as delegated by the Quality Assurance Manager or designate.

Requirements

We are looking for a candidate with:

  • A degree or diploma in a science-related discipline;
  • 2-5 years QA experience in a GMP or ISO testing or production facility;
  • GMP experience will be an asset;
  • Fluent English language skills;
  • Excellent communication skills, both written and verbal;
  • 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);
  • Proactive attitude, self-discipline, and ability to demonstrate a high level of productivity;
  • Satisfactory work performance and attendance record;
  • Willingness to learn with the ability to retain information quickly and apply knowledge to various scenarios.

Salary and Benefits

The estimated salary range for this position is $60,000 - $80,000 per year, depending on experience. We offer excellent full-time benefits, including health & dental coverage, life and disability insurance, RRSP with 3% company match, paid holidays, and paid time off.

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