Documentation Coordinator Quality Assurance
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 to 2017, we were recognized by Profit 500 as one of Canada’s Fastest Growing Companies.
The position is accountable to address QA documentation activities listed in the major responsibilities. Work closely with Operations department to assist them in implementing and maintaining effective, risk based GMP processes, procedures and documentations.
Here is what we are looking for:
- College diploma required, Bachelor’s degree in Science is preferred and 1-2 years of previous QA experience.
- Good computer skills
- Knowledge of documentation control requirements to meet FDA/Health Canada regulations
- Must be detail-oriented and possess strong organizational and time management skills.
Here is what you will be responsible for (but not limited to):
- Responsible for issuance of batch production records, production forms, buffer forms and labels
- Responsible for logbook issuance and maintenance
- Scanning and uploading executed batch production records, buffer preparation forms, and Change requests and other GMP documents.
- Responsible for label storage room to be in control
- Archive executed, canceled, aborted batch production records and other QA documents such as completed Incident Reports, Shutdown Reports, logbooks, etc.
- Responsible for GMP documents archiving and retrieval.
- Prepare and maintain database for document issuance, archival and retrieval.
- Assist with other QA activities as assigned
Interested candidates can send their resume and cover letter to firstname.lastname@example.org. Please reference Quality Assurance Documentation Coordinator in the subject line. While we appreciate all interest in this opportunity, only qualified candidates will be contacted.
Therapure Biopharma Inc. will not be responsible for any agency referral fees arising from the use of resumes that currently exist in the recruitment database or have been forwarded to Therapure BioPharma directly or indirectly without an authorized agreement. Agency referrals will not be accepted unless approved by the Therapure Biopharma Inc. Human Resources team.
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.