Quality Assurance Specialist Plasma Protein
Therapure Biopharma Inc. is a biopharmaceutical company focused on complex biological therapeutics and technologies. It is comprised of three divisions: Therapure Biomanufacturing which provides contract development and manufacturing (CDMO) services to global clients; Therapure Innovations, focused on research and development of proprietary therapeutics and platform technologies in the areas of anaemia, liver disease and organ preservation; and Therapure Biologics dedicated to the development of plasma protein therapeutics through an innovative proprietary manufacturing technology.
We are growing! In fact, from 2014-2017, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
The Plasma Protein group interacts with the manufacturing and quality groups according to a client-CDMO model. The QA specialist will be the primary point of contact for GMP compliance review from the client perspective. The QA specialist will provide leadership and guidance during implementation of a quality system within the R&D lab. Ability to work with limited supervision, comfortable making decisions.
Here is what we are looking for:
- University degree or equivalent in Science or related
- 5-10 years’ Quality Assurance experience is an asset
- Expertise in biological assay development and validation is an asset
- Expertise in GMP compliance is an asset
Here is what you will be responsible for (but not limited to):
- Review the following documents for compliance with accepted GMP principles (and in the absence of a quality system which is independent of the CDMO)
- Executed GMP batch records
- Incident and deviation reports
- Investigation reports
- Engineering and tech transfer reports
- Analytical method development reports
- Assay qualification protocols and reports
- Provide plasma protein lab with guidance with respect to ICH guidelines as it relates to development and validation through the product life cycle.
- Provide guidance on best practices with respect to assay development
- Audit process and assay development activities performed in the plasma protein lab for compliance with accepted standards
- Review regulatory submissions
- Performs additional duties as required.
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference Quality Assurance Specialist, Plasma Protein in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
NOTE:All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Therapure is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process, applicants are asked to make their needs/requirements known. Please notify Human Resources at HR@therapurebio.com for assistance.