Manufacture products by operating equipment according to the Master Batch Record (MBR).
Complete GMP documentation (MBRs, labels, logbooks, validation records) with accuracy and integrity.
Independently run at least two process types and perform all required in-process checks (IPCs).
Conduct ERP data entry and verification checks.
Perform intermediate troubleshooting and optimize equipment settings.
Fully disassemble, clean, and reassemble equipment and rooms per controlled procedures.
Notify supervisors of any processing issues, safety incidents, or concerns regarding product quality.
Maintain tools, equipment, and GMP areas in proper condition.
Retrieve, move, and store materials as needed.
Participate in the Train-the-Trainer program and coach other operators.
Support OPEX initiatives (Kaizen, SMED, OEE, 5S).
Perform other duties as assigned.
Experience and Qualifications :
1+ year of experience in a GMP manufacturing environment (pharmaceutical preferred).
High School diploma or equivalent.
Ability to wear required Personal Protective Equipment.
Mechanical aptitude with high-speed machinery.
Basic knowledge of Windows applications, SAP, and MSCA.
Understanding of GMP standards and Health & Safety procedures (OH&S Act, WHMIS).
Strong interpersonal and teamwork skills.
Solid math and writing skills (online assessment required for interview consideration).
Ability to multitask, plan, and solve routine problems independently.
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Operator • Stouffville, ON
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