Quality Assurance Specialist

Ottawa, Ontario / Full-Time

Job Summary

We are seeking a dedicated and dynamic individual to join our quality assurance team in Ottawa, Ontario. The successful candidate will possess experience in quality assurance and be able to work with an interdisciplinary team in a dynamic and high-paced environment.

PanTHERA CryoSolutions is a company that specializes in developing novel cryoprotectants for the preservation of cell and tissue constructs for regenerative medicine and cellular therapy applications. Our patented ice recrystallization inhibitor (IRI) technology exceeds our competitors’ products by providing superior cryoprotection which increases cell recovery and product quality for our customers. 

We are proud of our passionate, high-performance culture – one based on a set of values that are the cornerstone of who we are and how we hold ourselves accountable. Founded in 2018, we are headquartered in Edmonton, Alberta and operate our chemical synthesis and manufacturing facility in Ottawa, Ontario. We offer a collaborative and highly innovative work environment founded upon scientific excellence. 

Responsibilities

      • Work as a part of an interdisciplinary team to develop PanTHERA’s Quality Management System.
      • Draft, edit and maintain appropriate QA records. Revising and creating new standard operation procedures (SOPs).
      • Responsible for document control and record management.
      • Responsible for implementing the company’s Corrective Action and Preventive Action (CAPA) system.
      • Develop and ensure the compliance of procedures and policies in alignment with Good Manufacturing Practices.
      • Monitor Quality Assurance and Quality Control practices to ensure appropriate and effective implementation throughout the company.
      • Review, manufacturing and release testing records for approval.
      • Responsible for reviewing raw materials records for release.
      • Responsible for managing supplier/vendor quality.
      • Responsible for conducting out-of-spec investigations.
      • Ensure QA deliverables are met on time.
      • Hosts, participates, supports, conducts and when required leads audits to ensure compliance to all required regulatory agencies as well as company policies.

 

Qualifications

      • BSc degree in relevant discipline is required.
      • Good understanding of GMP, USP and ICH guidelines is required.
      • 2+ years of relevant experience developing, running and/or participating in quality assurance programs is required. Prior experience in the pharmaceutical or biotechnology industry is required.
      • Experience writing and revising controlled documents is required.
      • Highly adaptable and responsive to new priorities.
      • Effective written and oral communication skills.
      • Focused team-oriented player, with a strong work ethic is required.
      • Enthusiasm to tackle difficult problems, learn new technologies, and work in an exciting, high paced environment is a must.

 

Equity, Diversity and Inclusion Statement

PanTHERA CryoSolutions is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

 

How to Apply

To apply to this position, please send a cover letter and your CV to careers@pantheracryo.com.

 

This position will remain open until it is filled.