Toronto, Ontario – Lab Documentation Specialist

Reports to: Manager, Reporting and Quality Control

Position Summary:

Under the direction of the Departmental Manager, prepares documentation to support sample analysis and method validation projects while ensuring compliance with the OECD Principles of Good Laboratory Practice, established Standard Operating Procedures (SOPs), and other applicable regulatory requirements. In addition, QC data review may be performed when needed.

Duties and Responsibilities:

  1. Prepare Analytical Procedures (APs), Study Plans and Method Validation Plans as required.
  2. Write Bioanalytical Study Reports following eCTD guidelines and compile associated summary data tables when required
  3. Write Method Validation Reports and compile associated summary data tables when required.
  4. Participate in archiving, compiling study documents, photocopying and scanning of bio-study documents as required.
  5. Ensure that all documentation is accurate and in accordance with SOPs and regulatory guidance.
  6. Act as a back-up to the Manager, Reporting and Quality Control, when required.
  7. Assist in co-ordinating 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.
  8. 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.
  9. Provide feedback and findings regarding documentation discrepancies to the Manager, Reporting and QC, and/or Production Supervisor in a timely fashion.
  10. Conduct all work in compliance with SOPs, GLP and to observe all regulatory guidelines.
  11. Ensure accurate and complete documentation of all bioanalytical study source documents and/or forms according to company’s SOPs, GLP and other applicable guidelines.
  12. Assist with responses to any deficiency questions from regulatory agencies.
  13. Must be able to work well and effectively in a team.
  14. Exhibit excellent interpersonal, written and computer skills.
  15. Present a professional attitude and motivation to produce consistently high quality work.
  16. 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:

  • Minimum university degree, B.Sc. (preferably with analytical chemistry or related subject).
  • At least 5 years of Bioanalytical Lab QC and/or Report Writing experience.
  • Experience in a CRO environment is an asset, preferably where bioanalysis is performed.
  • High proficiency in the use of Microsoft Word, Excel and Adobe Acrobat (able to adhere to eCTD requirements).
  • Attentive to details, good initiative and able to work under pressure with changing priorities.
  • Must be able to work effectively as part of a team and individually.
  • Has great interpersonal skills and exhibits high level written skills.

Please send your resume to resumes@biopharmaservices.com