Title: Manufacturing Operator
Duration: 12 months
Working Hours: Candidates must be available to work any shift, with the understanding that shifts may change regularly.
Must be fluent in French
 
Job Summary:
In compliance with established policies, guidelines, procedures, manufacturing batch records, and in accordance with Good Manufacturing Practices (GMP), as well as health, safety, and environmental prevention measures and the business procedures/processes of the Montreal Site, the main duties of the Manufacturing Operator are as follows:

• As a member of the process-centered team, the Manufacturing Operator is responsible for manufacturing various dosage forms and performing the different stages of processes such as weighing, granulation, blending, compression, encapsulation, coating, and inspection of solid, semi-solid, or liquid dosage forms according to their professional specialty, while meeting criteria across multiple dimensions: Safety, Quality, Execution, Costs, and People.
• The operator is also responsible for cleaning and maintaining accessories and equipment in their area as well as their workstation.
• They must perform the production step under their responsibility, carry out the required inspections and controls, and document their actions in accordance with the manufacturing batch record and standard work charts.

 
Major Responsibilities:
The following tasks are performed in compliance with established policies, guidelines, procedures, manufacturing batch records, and in accordance with Good Manufacturing Practices, health, safety, and environmental protection measures, business procedures/processes of the Montreal Site, and standard work.
Level 1
(The Level 1 operator may be required to perform a combination of the following tasks)

• Cleaning (various types of cleaning) of certain parts, rooms (floors, walls, sinks, etc.), containers, and work area.
• Disassembly, cleaning, and assembly of production equipment according to procedures and GMP, following established standard work methods where applicable.
• Planning of cleaning activities to optimize production schedules and use of cleaning rooms.
• Verification of the condition of parts and/or equipment for cleanliness and general condition.
• Start-up of certain production equipment.
• Execution of room or section clearance.
• Evaluation of equipment and product quality.
• Proper documentation (manufacturing batch records, logs, cleaning labels, standard work charts, etc.) in accordance with GMP rules and verification of documentation.
• Printing and/or inspection of tablets or capsules according to standards.
• Execution of preventive maintenance (TPM).
• Punch polishing.
• Waste management (trash and/or pharmaceutical waste).
• Storage of parts.
• Follow up on requests with specialists or supervisors.
• Handling of certain equipment and products (powders, cores, tablets).
• Verification of raw materials.
• Execution of sanitation tasks.
• Execution of certain reconciliations.
• Maintaining adequate inventory of certain products/or materials, and/or supplies.

Occasional replacement of Level 2 Operators

• Identification of problems and proposal of solutions.
• Participation in T0–T1 meetings and the T1 continuous improvement loop.
• Training of colleagues.
• Active participation in the continuous improvement program and submission of ideas through the T-cards system.
• May be required to participate in team committees if required (e.g., HSE, operational excellence, CCM, special projects, job evaluations, 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 of ointments, creams, or liquids in accordance with manufacturing batch records.
• Following manufacturing instructions and parameters in the batch record and documentation.
• Execution of 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).
• Management and appropriate use/selection of tare weights.
• Monitoring and documentation of parameters and product quality.
• Proper documentation (manufacturing batch records, logs, cleaning labels, standard work charts, etc.) in accordance with GMP rules and verification of documentation.
• Handling of powders, cores, tablets, capsules, liquids, and/or semi-liquids.
• Cleaning and start-up of production equipment.
• Reconciliation.
• 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 of raw materials.
• Physical inventory of certain raw materials.
• Dispensing of certain raw materials.
• Loading and unloading of certain equipment.
• Work planning.
• Training of colleagues.
• Participation in T0–T1 meetings and the T1 continuous improvement loop.
• Adherence to standard work charts.
• Active participation in the continuous improvement program and submission of ideas through the T-cards system.
• May be required to participate in team committees if required (e.g., HSE, operational excellence, CCM, special projects, job evaluations, 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)

• Oversees improvement of performance and standard work using continuous improvement approaches and tools.
• Acts as a leader using continuous improvement tools and evaluates value-added activities.
• Mobilizes the process-centered team to achieve shift production objectives.
• Facilitator and resource person for the team.
• Supports and assists the team in meeting team objectives.
• Coordinates work organization and resources.
• Anticipates problems and serves as a resource for problem resolution.
• Works closely with supervisors.
• Proper documentation (manufacturing batch records, logs, cleaning labels, standard work charts, etc.) in accordance with GMP rules and verification of documentation.
• Communicates expectations to the team.
• Performs short-interval controls
• Participation in T0–T1 meetings and the T1 continuous improvement loop.
• Ensures relevant information is passed on to the next shift.
• Solicits and manages ideas from colleagues and promotes the T-cards system.
• Training of colleagues.
• Active participation in the continuous improvement program and submission of ideas through the T-cards system.
• May be required to participate in team committees if required (e.g., HSE, operational excellence, CCM, special projects, job evaluations, etc.).
• May be required to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.)

 
Must-haves:

• High school diploma or equivalent.
• Knowledge of GMP (an asset).
• 2 years of experience in the pharmaceutical field or related field (an asset).
• Mechanical aptitude and computer skills.

 
 
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. This position’s starting pay is: $ 28.14/hr.