Description:
Reporting to the Manager, Sterile Compounding, the Cleanroom Operations Supervisor is responsible for overseeing daily cleanroom operations and ensuring the facility meets the highest standards of cleanliness, safety & regulatory compliance. This role manages production activities, staffing, and scheduling to achieve operational goals, and supports the recruitment, training, and performance management of compounding and cleaning personnel. The Cleanroom Operations Supervisor enforces strict protocols, monitors environmental conditions, and supports regulatory inspections and audits. Additional responsibilities include maintaining inventory, supporting payroll and documentation, addressing employee relations in collaboration with HR, and supporting complaint resolution.
- Oversee and supervise daily cleanroom operations to ensure smooth, efficient functioning and maintain the facility to the highest standards of cleanliness.
- Monitor attendance, productivity, workflow, and enforce SOPs, policies, and best practices.
- Manage production activities to meet schedules and goals, including creating, reviewing, and adjusting work schedules and production plans.
- Organize operations and staffing to ensure all tasks are completed efficiently; anticipate workflow needs, adjust staffing levels, and provide coverage as required.
- Support recruitment, training, and performance management of direct reports; supervise compounding and cleaning personnel.
- Provide ongoing training on cleanroom standards, safety protocols, compounding techniques, and quality control measures (media fill, glove fingertip testing, air and surface sampling, and sterile compounding procedures).
- Perform environmental monitoring, including air and surface sampling for cleanroom and anteroom areas, and conduct glove fingertip and media fill testing as required; assist in coordinating assessments for cleanroom technicians.
- Conduct daily briefings, assign tasks, and provide coaching, feedback, recognition, and corrective guidance.
- Ensure accurate and timely completion of batch records, compounding logs, cleaning logs, and environmental monitoring records.
- Ensure proper handling of hazardous drugs.
- Participate in incident investigations and corrective actions.
- Support annual evaluations and recertification of cleanroom staff; review quality events with staff; oversee attendance and punctuality.
- Ensure compliance with ISO standards, NAPRA, and all applicable regulatory requirements; implement and enforce cleanroom protocols and procedures.
- Conduct regular inspections, monitor environmental parameters, and validate staff hygiene and gowning protocols.
- Oversee sterility testing activities and participate in certificate of analysis processes for both hazardous and non‑hazardous areas; maintain related documentation.
- Maintain accurate inventory of drugs and supplies, including purchasing, receiving, checking expiry dates, scheduling counts, and overseeing final packaging of sterile preparations.
- Review and enter staff payroll/timesheets, ensuring accuracy and proper use of time off options according to company policy.
- Address employee issues in collaboration with management and HR; support complaint management, ensuring concerns are communicated, addressed, and documented.
- Participate in regulatory inspections and audits.
- Assist with batch dispensing, batch approval in Pharmacy Keeper (IV Workflow), and other sterile processing activities.
- Maintain compliance with federal, provincial, and local laws, accrediting body standards, and company policies; contribute to policy and procedure reviews.
- Maintain detailed logs and documentation of cleaning activities, environmental conditions, and operational processes.
- Perform other duties as assigned.
Qualifications:
- Must be a Registered Pharmacy Technician in good standing with the Ontario College of Pharmacists.
- Minimum of 5 years of experience in sterile compounding, including at least 2 years in a leadership or supervisory capacity.
- Strong understanding of NAPRA and USP regulatory standards; formal training or demonstrated knowledge is considered a significant asset.
- Previous experience in a pharmaceutical environment, hospital pharmacy, or large scale sterile compounding facility is preferred.
- Proficient in Microsoft Office and relevant software applications, including Pharmacy Keeper and NAV Inventory systems.
- Training and experience in Beyond Use Date (BUD) assignment is an asset.
Physical Demands & Work Environment
The physical demands and work environment characteristics described below are representative of those required to successfully perform the essential functions of this role.
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Work is performed in a sterile cleanroom environment, requiring strict adherence to established protocols, including frequent cleaning and disinfecting activities throughout the shift, in accordance with standard operating procedures.
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The role involves physical activity, including prolonged periods of standing and walking, as well as bending, crouching, and sitting as required to complete assigned duties.
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The role requires repetitive use of the upper extremities, including frequent use of hands for tasks involving pinching, gripping, fine motor control, and handling materials and equipment.
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Duties include manual material handling, such as lifting, pushing, and pulling items weighing up to 50 lbs, including lifting from floor to waist and waist to shoulder as required.
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The role requires the ability to safely climb ladders and work at elevated heights when required for cleaning, maintenance, or material handling activities.
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Specific visual requirements are necessary to safely and accurately perform job duties, including close vision, distance vision, colour vision, depth perception, and the ability to adjust focus, particularly in a sterile compounding and production environment.
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The role requires the ability to wear required cleanroom personal protective equipment (PPE), including gowning, for extended periods of time while performing assigned duties.
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The work environment may involve exposure to chemicals used in cleaning, disinfecting, and operational processes, handled in accordance with established safety procedures and training.
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The employee may be occasionally exposed to fumes or airborne particles consistent with a controlled cleanroom or production environment.
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The noise level in the work environment is typically moderate.
