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CAN_Manufacturing Operations - Level 1
Spectraforce
Montreal, Quebec

2 hours ago

Job Description

Title: Manufacturing Operator
Location: Saint Laurent Montreal (CQM)
Duration: 6 months
Shift: Candidates must be available to work any of the shifts, understanding that the shifts can change regularly.

Night: 10:45 PM – 6:55 AM (Sunday to Friday)
Evening: 2:45 PM – 10:55 PM (Monday to Friday)
Day: 6:45 AM – 2:55 PM (Monday to Friday)


Job Summary:

Must ensure compliance with quality standards by following GMP regulations, corporate policies, and compliance standards during operations.

In accordance with established policies, directives, procedures, manufacturing instructions, and in compliance with Good Manufacturing Practices (GMP), health, safety and environmental prevention measures, and the business procedures/processes at the Montreal site, the main responsibilities of the Manufacturing Operator include:

As a member of the process-centered team, the Manufacturing Operator is responsible for manufacturing various dosage forms and performing different processing steps such as weighing, granulation, blending, compression, encapsulation, coating, and inspection of solid, semi-solid, or liquid dosage forms according to professional specialization, while respecting criteria in the areas of Safety, Quality, Delivery, Cost, and People.

Responsible for cleaning and maintaining accessories and equipment in the assigned area and work environment.

Responsible for performing assigned production steps, conducting required inspections and controls, and documenting actions according to manufacturing records and standard work charts.


Major Responsibilities:

All tasks are performed in compliance with established policies, directives, procedures, manufacturing records, Good Manufacturing Practices (GMP), health, safety and environmental protection measures, Montreal site business processes, and standard work.


Level 1

(The Level 1 operator will perform a combination of the following tasks)

  1. Cleaning (various types) of parts, rooms (floors, walls, sinks, etc.), containers, and work areas
  2. Disassembly, cleaning, and assembly of production equipment according to procedures and GMP following established standard work methods
  3. Planning cleaning activities to optimize production schedules and cleaning room utilization
  4. Verifying cleanliness and general condition of parts and/or equipment
  5. Starting certain production equipment
  6. Performing room or area clearance activities
  7. Evaluating equipment and product quality
  8. Proper documentation (manufacturing records, logs, cleaning labels, standard work charts, etc.) according to GMP rules and verification of documentation
  9. Printing and/or inspection of tablets or capsules according to standards
  10. Performing preventive maintenance (TPM)
  11. Punch polishing
  12. Waste management (garbage and/or pharmaceutical waste)
  13. Storage of parts
  14. Following up on requests with specialists or supervisors
  15. Handling certain equipment and products (powder, cores, tablets)
  16. Verification of raw materials
  17. Performing sanitation tasks
  18. Performing certain reconciliations
  19. Maintaining adequate inventory of certain products, materials, and/or supplies
  20. Occasional replacement of Level 2 Operators
  21. Identifying problems and proposing solutions
  22. Participation in T0–T1 meetings and T1 continuous improvement loop
  23. Training colleagues
  24. Active participation in the continuous improvement program and submitting ideas through the t-card system
  25. May participate in team committees if required (e.g., HSE, operational excellence, CCM, special projects, job evaluation, etc.)
  26. May perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.)

Level 2

(May occasionally perform Level 1 tasks)

  1. Weighing, granulation, blending, compression, coating of solid dosage forms, or manufacturing ointments, creams, or liquids in compliance with manufacturing records
  2. Following manufacturing instructions and parameters in the batch record and documenting activities
  3. Performing in-process controls
  4. Verifying, calibrating, and standardizing instruments and equipment
  5. Verifying and calculating certain adjustments (pH, volume)
  6. Performing transactions in certain computer systems (e.g., SAP)
  7. Managing and properly selecting/using tare weights
  8. Monitoring and documenting parameters and product quality
  9. Proper documentation according to GMP rules and verification of documentation
  10. Handling powders, cores, tablets, capsules, liquids, and/or semi-liquids
  11. Cleaning and starting production equipment
  12. Reconciliation
  13. Optimizing production parameters within permitted limits
  14. Production follow-up
  15. Preparing bulk for packaging
  16. Proper segregation and identification of toxic containers and pharmaceutical waste
  17. Palletizing raw materials
  18. Physical inventory of certain raw materials
  19. De-dispensing certain raw materials
  20. Loading and unloading certain equipment
  21. Work planning
  22. Training colleagues
  23. Participation in T0–T1 meetings and T1 continuous improvement loop
  24. Following standard work charts
  25. Active participation in the continuous improvement program and submitting ideas through the t-card system
  26. May participate in team committees if required
  27. May perform training follow-up tasks

Level 3

(May occasionally perform Level 1 or 2 tasks)

  1. Improving performance and standard work using continuous improvement tools and methodologies
  2. Acting as a leader using continuous improvement tools and evaluating value-added activities
  3. Mobilizing the process-centered team to achieve shift production objectives
  4. Acting as facilitator and team resource
  5. Supporting the team to achieve objectives
  6. Coordinating work organization and resources
  7. Anticipating problems and acting as a resource for problem resolution
  8. Close collaboration with supervisors
  9. Proper documentation according to GMP rules and verification
  10. Communicating expectations to the team
  11. Short interval controls
  12. Participation in T0–T1 meetings and T1 continuous improvement loop
  13. Ensuring proper information transfer to the next shift
  14. Soliciting and managing improvement ideas from colleagues and promoting the t-card system
  15. Training colleagues
  16. Active participation in continuous improvement initiatives
  17. May participate in team committees if required
  18. May perform training follow-up tasks

Education, Certification, Previous Experience

Regulatory requirement: N/A
Business needs: N/A

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

 
Applicant Notices & Disclaimers
  • For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
 
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.

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