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Process Operator, Compounding
1 week ago
The opportunity
Process Operator, Compounding - 12 month contract (Night Shift, Training on Days)
The Process Operator manufactures products by operating various equipment's in accordance with the master batch record (MBR) and in compliance with EH&S policies, GMPs and controlled procedures (SOP, EM, WI, JA, etc.) and performing troubleshooting and setup in an intermediate capacity, as required per department/site.
How you’ll spend your day
Performs duties in accordance with the master batch record (MBR) and in compliance with EH&S policies, GMPs, and controlled procedures (SOP, EM, WI, JA, etc.) Completes all GMP documentation (MBR, controlled procedures, labels, logbooks, validation documentation, etc.) in accordance with Data Integrity, in their area of responsibility. Independently runs at least two (2) process types and performs all required in process checks (IPCs). Performs ERP data entry and transactions, and verification checks as required. Conducts intermediate troubleshooting: Optimizes all settings, parameters and adjustment of equipment within area of responsibility or process type. Conducts intermediate equipment setup: Independently fully disassembles and sets up equipment within area of responsibility or process type, includes dismantling, cleaning, and assembly of processing equipment/rooms according to controlled procedures within area of responsibility. Notifies Supervisor when processing issues, product quality concerns and safety incidents occur. Ensures the proper care, use and condition of tools, equipment, rooms, and GMP area. Retrieves, moves and stores materials in appropriate areas of facility, as required per Department/Site. Attends the Train the Trainer Program. Performs training on equipment, controlled procedures, and best practices as required per Department/Site and acts as a coach to Process Operators. Understands and acts on areas of productivity losses, looks for and suggests solutions, support OPEX initiatives (i.e. Kaizen, SMED, OEE, 5S) Performs other duties as assigned.Your experience and qualifications
1+ year experience in GMP manufacturing environment. Preferred: 1+ year of relevant pharmaceutical experience. Minimum completion of High School required Ability to wear required Personal Protective Equipment Demonstrated mechanical ability with high-speed machinery Basic working knowledge of Windows applications, SAP, MSCA General knowledge of Pharmaceutical or comparable GMP industry Good knowledge of Health & Safety procedures, including, OH&S Act & WHMIS Good interpersonal skills with the ability to work as part of a high-performance team Strong writing skills: Prepare written materials that are accurate, clear, logical and well organized Math skills: Demonstrated ability to perform required computations, calculations and problems Planning/Organizational skills: Organize and manage time to complete tasks and projects. Ability to multitask Problem solving: Must demonstrate ability to identify alternatives and solve routine problems, e.g., ability to troubleshoot a process or equipment issue and explain the processes to others (training) Candidates shall be required to demonstrate mathematical and written skills by completing an on-line assessment to be considered for interview-
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