Sterile Production Technician

Clearwater, United States

About Us:

PharmaLabs is a leading provider of sterile injectables, oral preparations, and non-sterile lotions and gels. PharmaLabs prepares every product using only FDA approved ingredients and all medications are tested prior to release by an independent third-party laboratory. The safety of our patients and the quality of our compounded preparations are our highest priority.

Job Summary:

The Lead Sterile Compounding Technician plays a critical role in the production of high-quality sterile preparations at a 503A compounding pharmacy. This individual will serve as a technical expert and a mentor to other compounding technicians, ensuring all sterile compounding activities are performed accurately, efficiently, and in strict compliance with USP <797> (Pharmaceutical Compounding – Sterile Preparations), and other relevant state and federal regulations. The Lead Technician will be responsible for overseeing daily compounding operations, maintaining quality control, and assisting with training and competency assessments.

Reports To: Pharmacy Operations Manager - Sterile Compounding / Pharmacist-in-Charge

PharmaLabs is an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, national origin, gender, gender identity, sexual orientation, disability, or veteran status.

Responsibilities

  • Perform complex sterile compounding activities, including but not limited to, the preparation of intravenous admixtures, ophthalmic solutions, injectables, and other sterile dosage forms, in accordance with master formulation records and patient-specific prescriptions.
  • Utilize aseptic technique consistently and flawlessly within ISO Class 5 environments (e.g., laminar airflow workstations, biological safety cabinets, isolators).
  • Accurately measure, weigh, and mix active pharmaceutical ingredients (APIs) and excipients.
  • Operate and maintain sterile compounding equipment, including automated compounders, pumps, and filtering devices.
  • Ensure proper labeling, packaging, and storage of all sterile compounded preparations.
  • Serve as a role model and resource for best practices in USP <797> compliance and aseptic technique.
  • Perform daily quality checks on compounded products, ensuring accuracy, clarity, and integrity.
  • Assist with environmental monitoring activities (e.g., viable and non-viable particle counting, surface sampling) and ensure proper documentation.
  • Monitor and ensure adherence to garbing procedures, hand hygiene, and facility cleaning protocols.
  • Identify and report any deviations, errors, or potential quality issues to the supervising pharmacist or manager.
  • Assist in maintaining and reviewing compounding records, logs, and quality control documentation.
  • Provide guidance, mentorship, and on-the-job training to other sterile compounding technicians.
  • Assist the Pharmacy Operations Manager or Pharmacist-in-Charge with conducting initial and ongoing competency assessments for sterile compounding personnel (e.g., media-fill testing, gloved fingertip/thumb sampling).
  • Help to organize and optimize daily workflow within the sterile compounding suite.
  • Foster a collaborative and quality-focused team environment.
  • Participate in the onboarding of new sterile compounding technicians.
  • Monitor and manage inventory of sterile compounding supplies, APIs, and excipients, reporting needs for reordering.
  • Ensure proper storage conditions for all compounding materials.
  • Perform routine cleaning and maintenance of sterile compounding equipment and primary engineering controls (PECs) as per SOPs.
  • Report equipment malfunctions or maintenance needs promptly
  • Communicate effectively with pharmacists, other technicians, and management regarding compounding status, issues, and needs.
  • Maintain accurate and detailed compounding records, logbooks, and cleaning records.
  • Assist in the development and revision of Standard Operating Procedures (SOPs) related to sterile compounding.

Must Have

  • Exceptional aseptic technique and meticulous attention to detail.
  • Strong understanding of sterile compounding calculations and pharmaceutical measurements.
  • Excellent organizational and time management skills.
  • Ability to work accurately and efficiently in a fast-paced, highly regulated environment.
  • Proficiency in pharmacy computer systems and compounding software.
  • Strong communication and interpersonal skills, with the ability to teach and mentor others.
  • Ability to identify and resolve issues independently or by escalating appropriately.
  • Physical dexterity and ability to stand for long periods, lift moderate weight (up to 25 lbs), and perform repetitive tasks in a sterile environment.

Certification/Licensure

  • Current, active, and unrestricted Pharmacy Technician registration/licensure in the state of Florida.
  • Sterile Compounding Certification (e.g., Compounded Sterile Preparation Technician - CSPT by PTCB) required. PharmaLabs will assist in acquiring this once hired.
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How Do We Measure Success?

  • Attendance
  • Job Knowledge & Quality of Work
  • Communication & Collaboration
  • Initiative & Problem-Solving
    • Error Rates or Out-of-Specification Incidents
    • Department Output Volume per Shift
    • Batch Turnaround Time 
    • On-Time Batch Delivery Rate
    • Percentage of Wasted/Discarded Product 
    • Customer Complaint Rate