Lead Registered Pharmacy Technician (503A)Position Overview
The Lead Registered Pharmacy Technician provides advanced technical and operational support to pharmacists in a 503A compounding pharmacy. Along with completing routine compounding, documentation, and administrative responsibilities, this position serves as a lead resource for the technician team. Responsibilities include coordinating daily workflows, supporting technician orientation and training, monitoring inventory, and assisting the Pharmacist-in-Charge (PIC) with quality assurance and regulatory activities.
All responsibilities must be performed within the technician's authorized scope under state law, applicable regulatory requirements, written protocols, and facility Standard Operating Procedures (SOPs).
Minimum Qualifications
- Registration and Certification: Active registration as a Pharmacy Technician with the State Board of Pharmacy is required. An active Pharmacy Technician Certification (CPhT) is also required. The employee must maintain an unrestricted state registration and current national certification for the duration of employment.
- Education: High school diploma or equivalent required. Formal education through an accredited pharmacy technician program or comparable training is preferred, but not mandatory.
- Experience: Three to five years of experience in pharmacy, healthcare, pharmaceutical manufacturing, or a related setting is preferred. Experience with pharmaceutical compounding or operations involving regulated quality systems is highly desirable.
- Regulatory and Technical Expertise: Working knowledge of pharmacy requirements, FDA standards applicable to 503A facilities, and USP General Chapters <795>, <797>, and <800> is expected. Familiarity with HIPAA Privacy, Security, and Breach Notification requirements relating to Protected Health Information (PHI) is also required.
- Leadership Training: Prior to performing delegated functions, the technician must complete required facility leadership training, SOP instruction, safety evaluations, and other applicable competency requirements and sign a written protocol with the Pharmacist-in-Charge.
- Required Skills: Strong leadership, communication, organizational, and problem-solving abilities; exceptional attention to detail; proficiency with pharmacy management software; basic mathematical skills necessary for compounding calculations; and the ability to consistently apply established SOPs.
Essential Duties and Responsibilities
The Lead Registered Pharmacy Technician may perform the following functions under the direct supervision of a licensed pharmacist and within the limits of state regulations and facility protocols:
- Daily Workflow Management: Coordinate technician assignments and organize daily schedules for compounding, packaging, cleaning, and related operational activities to support efficient pharmacy workflow.
- Technician Training and Orientation: Provide hands-on instruction and practical guidance to new technicians and trainees regarding facility SOPs, aseptic practices, hand hygiene, garbing procedures, compounding calculations, equipment use, and other required technical processes.
- Quality and Documentation Review: Support the PIC and Quality Specialist by conducting preliminary daily checks of batch records, environmental monitoring documentation, cleaning records, and related operational paperwork to identify missing or incomplete information before forwarding records to Quality.
- Inventory and Material Management: Handle and transport medications, APIs, excipients, and other pharmacy materials. Monitor inventory quantities, coordinate replenishment of raw materials and supplies, and review applicable Certificates of Analysis (COAs).
- Medication Preparation: Compound and fill Compounded Nonsterile Preparations (CNSPs) and Compounded Sterile Preparations (CSPs) after successfully meeting all required competency standards, including media-fill and glove fingertip testing.
- Labeling Operations: Prepare, print, verify, and apply labels to medication containers and master compounding batches, ensuring all required information is accurate.
- Pharmacy Documentation: Maintain complete and accurate batch records, equipment documentation, temperature records, inventory records, and other required pharmacy documentation.
- Electronic Data Management: Enter prescription information, patient profile data, compounding records, and other required information into authorized pharmacy management systems.
- Compounding Support: Assist pharmacists with sterile and nonsterile compounding activities only when the assigned function is permitted by law and specifically authorized under the applicable written protocol.
- Employee Identification: Wear a clearly visible identification badge displaying the technician's first name and the official designation “Lead Registered Pharmacy Technician.”
- Protocol Acknowledgment: Review, sign, and date the initial written protocol and all subsequent amendments to demonstrate understanding and acceptance of assigned responsibilities.
- Professional Appearance and Hygiene: Wear approved work attire, including appropriate clothing or scrubs and non-slip footwear. Maintain proper personal hygiene and comply with all hand-hygiene, garbing, gowning, and cleanroom-entry procedures.
- License and Certification Compliance: Monitor expiration dates and complete all required continuing education and renewal requirements to maintain active, unrestricted state pharmacy technician registration and CPhT certification. Promptly report any change in registration, certification, or eligibility status to the PIC.
- Regulatory and SOP Compliance: Follow State Board of Pharmacy requirements, OSHA standards, facility policies, SOPs, and all other applicable requirements governing assigned duties and pharmacy operations.
Prohibited Activities
The Lead Registered Pharmacy Technician must not perform activities that are outside the legally authorized scope of a pharmacy technician or that require independent pharmacist judgment. Prohibited activities include:
- Accepting, receiving, or transcribing oral or telephone prescription orders.
- Entering or remaining in the pharmacy when a licensed pharmacist is not physically present and actively on duty.
- Performing duties that require professional discretion, clinical decision-making, or independent judgment within the practice of pharmacy.
- Performing compounding or other technical functions before completing required training and competency assessments or before the applicable responsibility has been authorized through a signed written protocol.
- Failing to promptly report actual or suspected medication-quality issues, contamination concerns, regulatory violations, or other circumstances requiring notification or reporting.
- Accessing, reviewing, discussing, using, or disclosing PHI without appropriate authorization or in a manner inconsistent with HIPAA's Minimum Necessary requirements.
Physical Requirements and Work Environment
- Facility Environment: Work takes place in a 503A compounding pharmacy containing designated areas for nonsterile compounding as well as controlled, ISO-classified cleanroom areas for sterile preparation.
- Physical Demands: The position requires prolonged periods of standing, regular lifting and movement of materials weighing up to 25 pounds, and sufficient fine motor coordination and manual dexterity to perform precise weighing, measuring, counting, labeling, and compounding activities.
- Personal Protective Equipment: Employees must follow all facility PPE requirements based on their assigned duties and work areas. Required protective equipment may include bonnets or hair coverings, masks, pharmacy garb, booties or shoe covers, protective eyewear, and gloves. Proper PPE use is essential for employee safety and for maintaining product sterility, quality, and integrity.
Pay: $25.15 - $30.28 per hour
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
