Toronto, Ontario – QC Lab Specialist

Reports to: Manager, Reporting and Quality Control

Position Summary:

Under the direction of the Departmental Manager, reviews documentation and raw data to ensure compliance with the OECD Principles of Good Laboratory Practice, established Standard Operating Procedures (SOPs) and other applicable regulatory requirements.

Duties and Responsibilities:

  1. Review all data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidance.
  2. Co-ordinate various project activities with other departments such as (but not limited to) QA, PK/Stats, Project Management, Business Development and resolve all issues in a very efficient and timely manner.
  3. Have flexibility work long hours, to stay late, or come in over weekends to ensure deadlines are met, on an irregular or as-needed basis to ensure project/study deliverables to other stakeholders are met.
  4. Provide feedback and findings regarding documentation discrepancies to the Manager, Reporting and QC, and/or Production Supervisor in a timely fashion
  5. Prepare bioanalytical tables, reports and plans and respond to any deficiency questions from regulatory agencies.
  6. Involve in any audits performed by external auditors, i.e. Canadian HPFBI, US FDA, EU/AU agencies.
  7. Must be able to work well and effectively in a team.
  8. Exhibits good interpersonal skills, written skills, a professional attitude and motivation to produce consistently high quality work.
  9. Any other duties assigned by the Lab Management.

In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:

  1. Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  2. Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  3. Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  4. Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.

 Qualifications:

  • Sc. in Analytical chemistry or related subject or College Diploma in chemical engineering or related subject
  • Minimum of 2 years of related experience

Please send your resume to resumes@biopharmaservices.com