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Quality Control Technician

2 weeks ago

Hamilton, Canada Centre For Probe Development And Commercialization Full time

The Centre for Probe Development and Commercialization (CPDC) is a leading provider, on a global basis, of next-generation radiopharmaceuticals that are used daily for the detection and treatment of human diseases such as cancer.
Radiopharmaceuticals are perishable products that require just-in-time manufacturing on a daily or weekly basis to ensure supply demands are met without interruption. CPDC's success in the radiopharmaceutical industry results from the ability of our talented and committed staff to develop and manufacture high quality products, while adhering to international regulations governing nuclear safety, transportation of dangerous goods and pharmaceutical manufacturing.
**About the role**:
As a **QC Technician**, you will be responsible for working in accordance with company policies and within GMPs while contributing your technical expertise to support current products and develop future drugs within the company portfolio.
**Location: Toronto**
**Duties/Responsibilities include**:

- Perform quality control (release & retrospective) testing of finished drug products according to standard testing methods (STMs), including analytical chemistry, microbiological tests and other tests according to the USP, EP. etc.
- Coordinate quality control (release & retrospective) testing of drug substances with contract laboratories or contract research organizations according standard testing procedures, USP or EP.
- Assist with method validation tasks as per approved protocols under supervision of or with guidance from more senior staff.
- Conduct all work in accordance with the company Standard Operating Procedures (SOPs) and raise any deviations immediately to the attention of Lab Management and Quality Assurance.
- Conduct peer review of laboratory records; create the release certificate of analysis.
- Write technical documents (e.g. draft specifications, test reports, data summaries, investigations, CAPAs), and revise standard operating procedures, test methods, controlled forms, etc.
- Assist in training of other colleagues.
- Perform routine quality operations including calibration/maintenance of equipment and inventory/material management of incoming raw materials/container closures and analytical reagents, when required.
- Responsible for maintenance of documentation to fulfill applicable regulatory requirements relating to nuclear safety (e.g. radioactive material transfer forms).
- Responsible for the housekeeping of the facility including the disposal of waste through the appropriate waste-streams.
- Work as a member of a team to achieve all outcomes.
- Plan, implement, and successfully complete assigned tasks in a timely fashion ensuring consistent high quality.
- Conduct investigations for testing failure and non-conformances and implement corrective actions.
- Adhere to GMP regulations by maintaining complete records pertaining to all aspects of training, analytical testing, routine operations, and equipment maintenance.
- Understand and work under the Health Canada and FDA GMP requirements for sterile pharmaceuticals.
- Understand and work under the Canadian Nuclear Safety Commission regulations.
- Ensure compliance with Health and Safety for all policies, procedures and regulations applicable to their work.

*
Qualifications/Education: *
- College Diploma or B.Sc. in Chemistry, Biotechnology, or a related field;
- 1 to 3 years of related experience in analytical chemistry techniques such as HPLC, GC and TLC, and microbiology tests such as Bacterial Endotoxins or Sterility.
- Proficiency with equipment data processing software such as Empower (Waters HPLC).
- Proficiency with spreadsheets (e.g. Excel, Google Sheets), word processing software (e.g. Word) and ability to write technical documents and reports.
- Good communication skills (in English) and ability to work both independently and cooperatively in a team environment.
- Experience in a pharmaceutical cGMP environment, experience in aseptic operations (use of a BSC -Biological Safety Cabinet) and working under Canadian Nuclear Safety Commission regulations are assets in this role.
- This position requires flexibility in work schedule to support a nightshift-type production environment.
- Ability to lift and move heavy weights up to 23 kilograms is required.

*
CPDC offers: *
- Competitive compensation
- Medical and dental benefits, sick days & more
- Opportunity for long-term growth
- Professional & collaborative environment with experienced individuals in the field
- Join a passionate team making a difference in patients’ lives and Canadian