Certified Pharmacy Technician- Quality Assurance And Compliance

Overview: This positon is responsible for overseeing the quality control and performance improvement of sterile and non-sterile compounding operations within the pharmacy, and regularly reporting findings, concerns, and recommendations to the pharmacist-in-charge and/or company ownership, which shall have executive authority over such matters. This position shall be trained to be a pharmacy compounding regulatory (federal law, state law, USP <797>) and accreditation standards (ACHC/PCAB, USP <797> and USP <795>) expert.

• Schedule and oversee clean room certification
• Certification of pre-sterilization room, ante room, buffer room
• Viable air sampling and identification of CFUs
• Certification of all ISO 5 hoods, isolators and powder hoods
• Keeps up-to-date with ongoing changes in USP <797> to maintain compliance
• Potency Testing
• Employee Training and Employee Training Binder Maintenance
• Conduct employee training as applicable
• Maintain complete and thorough documentation of employee training per federal, state, and accreditation standards in employee training binders
• Standard Operating Procedures (SOPs)
• Identify SOPs that need revision
• Identify where new SOPs are needed and create to meet demands
• Make sure SOPs meet federal, state, and accreditation standards
• Maintain accreditation standards set by PCAB in sterile and non-sterile compounding areas
• Prepare for PCAB onsite inspection typically every 3 years
• Work with inspectors on inspection days to achieve successful inspections.
• Communicate as needed to maintain compliance and good relations
• Help prepare staff and facilities for inspection
• Schedule and oversee validation, calibration, and maintenance of all equipment related to sterile and/or non-sterile compounding
• Validation of Equipment
• Calibration of Equipment
• Maintenance of Equipment As required per SOPs and manufacturer manual and as needed
• Licensure and Certification Updating
• Maintain the most up-to-date copy of all facility and personnel licenses and certifications on the wall as required by state and federal laws.
• Apply for new facility licenses as requested by management, and renew current facility licenses as needed before expiration
• Environmental Testing
• Surface sampling
• Create Pharmacy Technician schedule detailing days to work and what stations and responsibilities and given technician has for the work day
• Or assign to other appropriate technician
• Manage team disciplinary issues appropriately according to company SOPs
• Work toward best resolution for both the company and employee
• Ex: Written plan of corrective action agreed to by employee
• Customer Service
• Handle higher level customer service complaints requiring management level involvement with superior customer service and goal of acceptable resolution of various customer complaints as possible
• Review incident reports written by all staff as filed and at quality control meetings with team members
• Develop resolutions with quality control team to avoid repeat incidents as possible (ex: update SOPs and train staff to better avoid a given incident type from occurring again in the future)
• Train staff as needed on best practices and company SOPs regarding customer service
• Work with team as needed to resolve customer service problems involving poor or inappropriate customer service
• Documentation Logs
• Sterility Testing
• Endotoxin Testing