Job Description

JOB SUMMARY
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.
DUTIES AND RESPONSIBILITIES
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
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.

Skills Required