Title:Manufacturing Operator Duration: 12 Months Location: Saint-Laurent, QC Note: Must be fluent in French and Candidates must be available to work any of the shifts, understanding that the shifts can change regularly.
Job Summary: In compliance with established policies, guidelines, procedures, manufacturing records, and Good Manufacturing Practices (GMP), as well as health, safety, and environmental prevention measures and the business procedures/processes of the Montreal Site, the main responsibilities of the Manufacturing Operator are: As a member of the process-centered team, the Manufacturing Operator is responsible for manufacturing various dosage forms and performing the different stages of the processes, such as weighing, granulation, blending, compression, encapsulation, coating, and inspection of solid, semi-solid, or liquid dosage forms according to their area of professional specialization, while respecting the different criteria in the following dimensions: Safety, Quality, Execution, Costs, and People.
Clean and maintain accessories and equipment in their area, as well as their workplace.
Perform the production stage under their responsibility, conduct the required inspections and controls, and document their actions according to the manufacturing record and standard work charts.
B. Major Responsibilities The following tasks are performed in compliance with established policies, guidelines, procedures, manufacturing records, Good Manufacturing Practices (GMP), health, safety, and environmental protection measures, business procedures/processes of the Montreal Site, as well as standard work. Level 1 (The Level 1 Operator will be required to perform a combination of the following tasks.)
Cleaning (different types of cleaning) of certain parts, rooms (floors, walls, sinks, etc.), containers, and their work area.
Disassembly, cleaning, and assembly of production equipment according to procedures and GMP, following established standard work methods where applicable.
Planning cleaning activities to optimize production schedules and the use of cleaning rooms.
Checking the condition of parts and/or equipment for cleanliness as well as the general condition of the part and/or equipment.
Starting up certain production equipment.
Performing room or section clearances.
Evaluating the quality of equipment and products.
Proper documentation (manufacturing records, logs, cleaning labels, standard work charts, etc.) according to GMP rules and verification of documentation.
Printing and/or inspection of tablets or capsules according to standards.
Following up on requests with specialists or supervisors.
Handling certain equipment and certain products (powder, cores, tablets).
Verification of raw materials.
Performing sanitation tasks.
Performing certain reconciliations.
Maintaining an adequate inventory of certain products and/or materials and/or supplies.
Occasional replacement of Level 2 Operators.
Identifying problems and proposing solutions.
Participating in T0–T1 meetings and the T1 continuous improvement loop.
Training colleagues.
Active participation in the continuous improvement program and submitting ideas through the t-cards system.
May be required to participate in team committees as needed (e.g., HSE, operational excellence, CCM, special projects, job evaluation, etc.).
May be required to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.).
Level 2 (May occasionally be required to perform Level 1 tasks.)
Weighing, granulation, blending, compression, or coating of solid dosage forms, or manufacturing ointments, creams, or liquids in accordance with manufacturing records.
Following instructions and manufacturing parameters in the manufacturing record and documentation.
Performing in-process controls.
Verification, calibration, and adjustment of instruments and equipment.
Verification and calculation of certain adjustments (pH, volume).
Transactions in certain computer systems (e.g., SAP).
Proper management and use/selection of tare weights.
Monitoring and documenting product parameters and quality.
Proper documentation (manufacturing records, logs, cleaning labels, standard work charts, etc.) according to GMP rules and verification of documentation.
Optimization of production parameters within permitted limits.
Production follow-up.
Preparation of bulk material for packaging.
Proper segregation and identification of toxic containers and pharmaceutical waste.
Palletizing raw materials.
Physical inventory of certain raw materials.
De-dispensing of certain raw materials.
Loading and unloading of certain equipment.
Work planning.
Training colleagues.
Participating in T0–T1 meetings and the T1 continuous improvement loop.
Following standard work charts.
Active participation in the continuous improvement program and submitting ideas through the t-cards system.
May be required to participate in team committees as needed (e.g., HSE, operational excellence, CCM, special projects, job evaluation, etc.).
May be required to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.).
Level 3 (May occasionally be required to perform Level 1 or Level 2 tasks.)
Ensures improvement of performance and standard work by using continuous improvement approaches and tools.
Acts as a leader by using continuous improvement tools and evaluating value-added activities.
Mobilizes the process-centered team to achieve the shift's production objective.
Acts as a facilitator and resource person within the team.
Supports and assists the team in meeting team objectives.
Coordinates the organization of work and resources.
Anticipates problems and acts as a resource person for problem resolution.
Works closely with supervisors.
Proper documentation (manufacturing records, logs, cleaning labels, standard work charts, etc.) according to GMP rules and verification of documentation.
Communicates expectations to the team.
Performs short-interval controls.
Participates in T0–T1 meetings and the T1 continuous improvement loop.
Ensures that relevant information is cascaded to the following shift.
Solicits and manages ideas from colleagues and must promote the t-cards system.
Trains colleagues.
Actively participates in the continuous improvement program and submits ideas through the t-cards system.
May be required to participate in team committees as needed (e.g., HSE, operational excellence, CCM, special projects, job evaluation, etc.).
May be required to perform training follow-up tasks.
Education, Certification, Previous Experience:
High school diploma or equivalent.
Knowledge of GMP is an asset.
2 years of experience in the pharmaceutical or related industry is an asset.
Mechanical aptitude and computer knowledge.
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is C$28.96/hr.