JOB SUMMARY

Reporting to the Manager, Sterile Compounding, the Cleanroom Production Lead is responsible for overseeing daily cleanroom operations and supporting the team to ensure the highest standards of quality, safety, and regulatory compliance. This role provides hands-on leadership and technical guidance to cleanroom personnel, oversees production activities, staffing, and scheduling to achieve operational goals, and supports the performance management of compounding and cleaning personnel. The Cleanroom Production Lead enforces strict protocols, plays a critical role in training, coaching and maintaining staff competency in aseptic technique, and supports regulatory inspections and audits. Additional responsibilities include maintaining inventory, supporting payroll and documentation,

DUTIES AND RESPONSIBILITIES

·       Oversee daily cleanroom operations to ensure efficient, accurate, and timely compounding operations.

·       Monitor attendance, productivity, workflow, and enforce compliance with SOPs, policies, and best practices.

·       Coordinate production activities to meet schedules and goals, including creating, reviewing, and adjusting work schedules and production plans.

·       Prioritize tasks and adjust workflow and staffing to ensure all tasks are completed efficiently; anticipate workflow needs, adjust staffing levels, and provide coverage as required.

·       Lead and deliver aseptic technique training to all cleanroom personnel, including Hazardous and Non-Hazardous sterile compounding including Narcotics.

·       Conduct performance management of direct reports, compounding and cleaning personnel.

·       Provide ongoing competency assessment, retraining, and quality assurance measures and sterile compounding procedures.

·       Compound non-hazardous and hazardous sterile preparations in compliance with approved formulations, SOPs, and regulatory requirements.

·       Ensure proper handling, containment, and workflow practices for hazardous drugs/preparations in accordance with USP <800> and NAPRA standards.

·       Conduct routine cleanroom observations and internal audits to assess compliance with SOPs and regulatory standards.

·       Ensure accurate and timely completion of batch records, compounding logs, cleaning logs, and environmental monitoring documentation.

·       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.

·       Report incidents, errors, or deviations to management in a timely manner.

·       Participate in incident investigations and corrective actions. review quality events with staff.

·       Support annual evaluations and recertification of cleanroom staff.

·       Ensure compliance with NAPRA standard of practice, and all applicable regulatory requirements; implement and enforce cleanroom protocols and procedures.

·       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 PharmacyKeeper (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.

·       Perform other duties as assigned.

QUALIFICATIONS

·       Minimum of 5 years of experience in sterile compounding.

·       Leadership or supervisory capacity is an asset.

·       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 PharmacyKeeper 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.

1. 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.
2. 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.
3. 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.
4. 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.
5. The role requires the ability to safely climb ladders and work at elevated heights when required for cleaning, maintenance, or material handling activities.
6. 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.
7. The role requires the ability to wear required cleanroom personal protective equipment (PPE), including gowning, for extended periods of time while performing assigned duties.
8. The work environment may involve exposure to chemicals used in cleaning, disinfecting, and operational processes, handled in accordance with established safety procedures and training.
9. The employee may be occasionally exposed to fumes or airborne particles consistent with a controlled cleanroom or production environment.
10. The noise level in the work environment is typically moderate.