Qc Lab Specialist - Toronto, Canada - Think Research

Think Research
Think Research
Verified Company
Toronto, Canada

1 week ago

Sophia Lee

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Sophia Lee

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Description



The Company
BioPharma Services Inc. is a subsidiary of Think Research.


BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients.

With this same dedication and vision in mind, these physicians brought life to BioPharma.


Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people.

The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients.

To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.


Why Us?

  • It's not every day that you have the chance to change the way your friends and family are cared for
  • Make an impact
  • Everything we do and we do it with passion is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
  • We're growing, and so will you with leaders who will support your development through mentorship and other opportunities
  • Collaborative, creative, dynamic and flexible work environment, with a startup spirit

The Role


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.


You Will Have The Opportunity To:

  • Review all data generated, ensuring that all documentation is accurate and in accordance with SOPs and regulatory guidance.
  • Coordinate 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.
  • Have flexibility work long hours, to stay late, or come in over weekends to ensure deadlines are met, on an irregular or asneeded basis to ensure project/study deliverables to other stakeholders are met.
  • Provide feedback and findings regarding documentation discrepancies to the Manager, Reporting and QC, and/or Production Supervisor in a timely fashion
  • Prepare bioanalytical tables, reports and plans and respond to any deficiency questions from regulatory agencies.
  • Involve in any audits performed by external auditors, i.e., Canadian HPFBI, US FDA, EU/AU agencies.
  • Must be able to work well and effectively in a team.
  • Exhibits good interpersonal skills, written skills, a professional attitude, and motivation to produce consistently highquality work.
  • 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:

  • Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  • Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  • 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.

What You Will Bring:


  • Minimum of 3 years of related experience
  • Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
  • We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
  • We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs._
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