Operations Associate I - Toronto, Canada - CCRM
Description
Department:
Operations
Position Summary:
As an Operations Associate I at CCRM, you will be part of a diverse manufacturing team focused on Good Manufacturing Practices (GMP) production projects for CCRM's GMP facility.
This position is required to work on-site to carry out the manufacturing activities in CCRM's GMP facility and process development lab.
You will work with the team to execute defined project tasks and bring new and innovative products to market. This role is required to work shifts and weekends.Responsibilities:
- Follow CCRM's policies, standard operating procedures (SOPs), GMP, and Good Documentation Practices requirements.
- Assist in writing and revising SOPs and master batch records describing operations of equipment and process.
- Responsible for cleaning, and documentation of equipment in cleanroom for use.
- Responsible to support process validation, process optimization and process development as required.
- Assist in the execution of the production batch records or other GMP documents. Ensure that the Grade A and B manufacturing areas are clean and remain in a state of control.
- Follow CCRM's safety procedures and use personal protective equipment, as required.
- Other process related tasks that may be assigned.
- Able to lift or carry up to 20 pounds.
Qualifications:
- Diploma or higher in biological or life science, pharmaceutical manufacturing, or a related field.
- Minimum five years of professional experience in Canada, including two years of GMP experience.
- Strong English written and verbal communication skills.
Desired Characteristics:
- Experience working in an aseptic manufacturing area.
- Work experience in cell and tissue culture.
- Knowledge of Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance principles.
- Knowledge of the Workplace Hazardous Materials Information System (WHMIS).
- Ability to work in team environments.
- Working knowledge of Microsoft Office.
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