Microbiology-environmental Sampling Technician Quality Control (Night Shift)
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 main responsibility for the QC Microbiology Environmental Sampling Technician is to perform monitoring of the manufacturing facility to provide assurance that all areas continue to operate under a state of control. This monitoring consists of non-viable particulate testing, viable air sampling and viable surface sampling.
Here is what we are looking for:
- Bachelor’s degree or Microbiology college diploma/certification or related scientific discipline
- Basic understanding of microbiology test methodologies.
- Knowledge and understanding of GMP, compendial test requirements, US and Europe Pharmacopea an asset.
- Basic understanding of data analysis, statistics and report preparation with knowledge of MS Word, Excel and Outlook.
Here is what you will be responsible for (but not limited to):
- Attend validation media fill training sessions to prepare for protocol execution.
- Perform environmental monitoring of new areas to support room performance qualification.
- Perform routine sampling of all qualified areas to ensure that all sampling frequencies are met as per current procedures.
- Perform spot checks of manufacturing personnel during filling operations to ensure strict adherence to aseptic technique/processing procedures.
- Log-in test samples for tracking purposes.
- Follow established procedures for use of released media that has a valid expiry date.
- Analyse, interpret and report data.
- Submit plates for microbial identification.
- If required, perform daily water sampling of manufacturing plant that could involve heights over 3 metres.
- Review environmental data associated with Grade C and D areas.
- Assist in collecting data to prepare quarterly and annual utility system trending reports.
- Participate in scheduled cleaning and other laboratory housekeeping duties.
- Employ good documentation practices when generating raw data, reports, SOPs and other documentation.
- Participate in environmental monitoring investigations with the Environmental Monitoring coordinator.
- Report to Environmental Monitoring Coordinator or Microbiology Supervisor/Manager any deviations from company procedures, or other discrepancies that may affect product quality or environmental monitoring results.
- Assist in identifying root causes and corrective actions for environmental monitoring excursions.
- Report Health and Safety incidents, accidents or potential hazards.
- Remain crossed trained on Microbiology test methods to act as a back up to Microbiologists for testing of raw material and product samples when required.
Interested candidates can send their resume and cover letter to email@example.com. Please reference QC Micro Environmental Tech (NIGHT SHIFT) 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.