Sterile Compounding Operations Specialist
Reports To: Compliance
Job Type: Full-Time
Location: Kansas City, MO/KS
Job Overview: On-Site Clean specializes in providing critical services in sterile compounding cleanroom environments, including cleaning, USP competency assessments, monthly environmental monitoring, and full cleanroom certification services to pharmacy clients across multiple states in the Midwest.
The Sterile Compounding Operations Specialist will be responsible for supporting multiple operational business lines offered by On-Site Clean. Support consists of conducting USP Sterile Compounding Competencies per USP Standards, managing sterile cleanroom cleaning services, and supporting service line expansion in the Kansas City market. This position requires knowledge of best practices for sterile compounding, how to operate inside ISO classified spaces, good documentation practices, and great communication skills. Precision, compliance-driven and highly detail oriented will be critical to success. The position will play an active role in client relations.
Specifically, this position will conduct:
- Evaluations of hand hygiene and garbing, and media fill competencies per USP Standards and State Board of Pharmacy requirements. The position will be responsible for documenting activities and findings per the forms provided.
- Assist with managing a team of cleaning technicians, ensuring adherence to pharmacy cleanroom standards and procedures. This will consist of initial and annual training of cleaning technicians, competency observations, assisting with cleaning on a regular basis, conducting quality checks of cleaning services, assisting with On-Site Clean portal management and documentation of task completion.
The position will be a hybrid role based in the Kansas City metro area, with time spent working from home and at client sites conducting services. There may be opportunities to travel outside the Kansas City metro area for additional team support.
Essential Duties and Responsibilities:
- Comply with all federal, state, and USP compounding regulations and standards.
- Comply with all On-Site Clean and client pharmacy’s policies, SOPs, and best practices.
- Maintain detailed knowledge of USP compounding standards and adapt as they evolve.
- Conduct gloved fingertip and thumb sampling via observation and media plate sampling immediately post garbing procedure for internal team members and external clients.
- Conduct media fill simulations via observation and media plate sampling of gloved fingertip/thumb and surface sampling for external clients.
- Follow procedures for handling, collecting and submitting samples for incubation.
- Follow good documentation practices on all required forms and logs.
- Conduct training per SOPs in ISO classified spaces. This will include proper hand hygiene and garbing procedures, and proper cleaning order per best practices/techniques in sterile cleanroom suites.
- Assist with managing daily operations, including portal management, client engagement and project execution.
- Assist with creating and maintain technician schedules and ensuring adequate staffing.
- Rotate on-call schedule with area team to address coverage needs.
- Cover cleaning shifts as needed in the event of staff call-ins to maintain operational continuity and client expectations.
- Effectively mentor technicians and lead technicians, while fostering high performance, knowledge sharing, and employee retention.
- Support continuous improvement initiatives locally and company-wide.
- Represent On-Site Clean in a professional and courteous manner in all interactions with clients and fellow personnel.
- Ability to communicate effectively to pharmacy technicians, pharmacists and pharmacy leadership as needed.
- Participate in in-service education programs provided or sponsored by On-Site Clean.
- Perform other duties as assigned by your supervisor.
Education and/or Work Experience Requirements:
- A minimum of 2 years of sterile compounding experience is required.
- Certification or registration as a pharmacy technician when required by law or pharmacy policy.
- Current knowledge of USP <795>, <797> and <800> compounding standards.
- Current knowledge of all applicable state and federal pharmacy laws, rules, and regulations.
- Organizational skills sufficient to maintain accurate records.
- Effective interpersonal, time management, and organizational skills.
- Proficient with computer software such as Adobe, Word, Excel, etc. to generate documents, charts and reports.
- Excellent customer service skills.
Physical Requirements:
- The employee is regularly required to stand, walk, and sit when visiting various pharmacy locations.
- The employee may be required to use a computer screen for long periods of time.
- The employee will need to be able to wear Personal Protective Equipment (PPE) for long periods of time, including a respirator.
- The employee will work in hazardous drug compounding areas that may require additional PPE.
Additional Requirements:
- Position working hours are generally Monday through Friday during normal business hours with occasional evenings and weekends as needed per client request.
- Will require travel to various pharmacy locations across the Kansas City, MO/KS Metro area.
- Will require reliable transportation to meet local travel requirements.
- If not at a client site, the position will work from home with a reliable internet connection.
- A positive growth mindset as the business scales.
Benefits:
- Health Insurance
- Dental Insurance
- Vision Insurance
- 401(k)
- Life insurance
- Vacation Time Off
- Paid Time Off (PTO)
- 6 Paid Holidays Off
Pay: $48,000.00 - $55,000.00 per year
Work Location: Hybrid remote in Kansas City, MO 64136
