Lab Coord/BA Chemist

WELL Health Technologies CorpToronto, ON
Onsite

About The Position

BioPharma Services Inc. is seeking a full-time Lab Coordinator/Bioanalytical Chemist to join their team. This role involves supporting lab operations, coordinating lab activities, managing supply chains, maintaining databases, and reviewing documentation. The position also includes performing method validation and bio-study analysis tasks, generating analytical test results, and ensuring compliance with regulatory requirements such as GLP, EMA, ICH, FDA, and TPD. The ideal candidate will have a science/life science or analytical chemistry background, experience working under GxPs, and strong computer and customer service skills.

Requirements

  • College Diploma in a related science/life science discipline
  • Experience may be substituted with education
  • Working knowledge of computers
  • Customer service skills including attention to detail, accuracy, confidentiality, and communication skills
  • Experience working under GxPs
  • Must be able to lift up to 50 lbs., bend, reach, climb stairs and stand for extended periods of time
  • B.Sc. or College Diploma in Analytical chemistry or related subject
  • Minimum of 1-3 years of related experience

Responsibilities

  • Receiving, storage and tracking of study samples.
  • Ordering, follow-up and maintenance of general lab supply inventories and lab storage room.
  • Database maintenance for study samples, reference standards, pipette verification/calibration and staff scheduling.
  • Study documentation review, including verification of good documentation practices and QC review of logbooks and data.
  • Preparation of reagents, stock solutions, mobile phase, reference standard weighing and perform sample extractions.
  • Working towards deadlines due to the time pressured nature of some studies.
  • Utilizing word processing, databases, spreadsheets, and specialized software on personal computers.
  • Flexibility in working outside of contracted hours and weekends on a rotational basis.
  • Communicating discrepancies to appropriate personnel and assisting with problem solving.
  • Coordinating and supporting lab activities and operations and any other supporting duties as assigned on an as needed basis.
  • Working in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Documenting and communicating any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  • Recording raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  • Exercising health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicating to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.
  • Performing method validation and biostudy analysis tasks in accordance with SOPs.
  • Having a good knowledge of analytical laboratory equipment’s common in the Bioanalytical Laboratory such as sample preparation equipment, general Laboratory equipment and LC-MS/MS.
  • Conducting all work in a good team environment focusing on meeting project timelines.
  • Providing assistance to plan and coordinate projects with responsibility to accommodate frequently changing priorities.
  • Generating analytical test results in compliance with all current applicable Standard Operating Procedures.
  • Generating method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.
  • Coordinating projects and work activities with Laboratory Management to meet established objectives.
  • Showing innovation on an ongoing basis to assist management in solving problems related to any bioanalytical issues and laboratory processes.
  • Providing assistance in troubleshooting and maintenance of laboratory equipment.
  • Assisting in reviewing Standard Operating Procedures.
  • Demonstrating excellent written and verbal communication skills.
  • Performing the job in a cost-effective manner.
  • Compiling and archiving study/validation data.
  • Performing the job according to an approved Protocols and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Working in a safe manner, complying with all relevant safety procedures and requirements.
  • Exhibiting good interpersonal skills, a professional attitude and motivation to produce consistently high quality work.
  • Performing other related duties assigned by the management.
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