Aseptic Manufacturing Operator

Position Overview:

Strive Outsourcing is seeking a skilled and detail-oriented Aseptic Manufacturing Operator to join our team. In this critical role, you will prepare custom sterile compounded medications while maintaining the highest standards of quality, accuracy, and regulatory compliance. Working under the direct supervision of highly qualified operations and quality leaders, this role will perform aseptic compounding activities, completes required documentation, maintains GMP cleanroom standards, and supports the safe production of large batch pharmaceuticals in accordance with Strive Outsourcing’s Standard Operating Procedures (SOPs).

Location: Alachua, FL (Monday - Friday)

Position Type: Full-Time

Schedule: Day shift

Key Responsibilities:

• Sterile Manufacturing: Follow proprietary formulations and established procedures to accurately and safely produce sterile injectable medications.
• Quality Control & Documentation: Perform ongoing quality checks, prepare samples for testing, and initiate investigations for deviations from established procedures.
• Collaboration: Work closely with the Operations Directors, Managers, and/or Supervisors, and Quality Assurance teams to maintain product integrity, accuracy, and regulatory compliance.
• Equipment Documentation: Maintain calibration logs for scales, electronic meters, and other manufacturing equipment. Accurately document quality procedures, production activities, and required compounding records.
• Cleanroom Maintenance: Maintain cleanroom cleanliness, organization, and compliance according to established procedures. Properly dispose of chemicals and waste materials according to safety protocols.
• Inventory Management: Monitor inventory levels, identify supply needs, report shortages to supervisors, and inspect materials for expiration or quality concerns.
• Compliance & Continuous Improvement: Participate in audits, inspections, competency assessments, and required continuing education activities to support ongoing compliance and operational excellence.
• Attendance and Punctuality: Show up on time and ready to work each day to support strict adherence to production.   

Required Qualifications:

• High school diploma or equivalent.
• Minimum of 1 year of pharmaceutical manufacturing experience with strong aseptic technique 
• Working knowledge of United States Pharmacopeia (USP) <795, 797>, USP <800>, and Food and Drug Administration (FDA) 503B Current Good Manufacturing Practice (cGMP) guidelines.
• Strong understanding of pharmaceutical calculations, medical terminology, aseptic technique, and sterile compounding processes.
• Ability to work efficiently in a fast-paced environment while maintaining exceptional attention to detail, accuracy, and quality standards.
• Ability to operate specialized equipment used in sterile compounding processes.

Preferred Qualifications:

• Technical Certificates or Training, Associates or Bachelors Degree in Science or with strong scientific background
• Prior experience working in a high-volume sterile compounding pharmacy, specialty pharmacy, 503A compounding pharmacy, or 503B outsourcing facility.
• Experience with cleanroom operations, environmental monitoring, quality assurance documentation, and regulatory compliance processes.
• Commitment to ongoing education and continuous improvement in sterile compounding practices.
• High level of attention to detail and experiences with Good Documentation Practices
• Responsible for assisting in the set-up of daily activities including staging of batches, equipment cleaning and set-up, and documenting in batch records and logbooks.
• Meet Right First Time (RFT) metrics by reducing error / deviations and completing corrections in a timely manner
• Maintain adherence to SOP’s, cGMPs and the manufacturing schedule
• Ability to perform and maintain aseptic gowning and media fill qualification
• Independently assist in compounding activities (training will be provided)
• Be able to complete periods of standing up to 6hrs per shift and be able to twist and lift product material during job shift
• Perform disinfectant and sanitation cleaning of aseptic areas for environmental control
• Assume other duties and responsibilities as directed by supervisors

Work Environment:

This position is primarily based in an onsite sterile cleanroom manufacturing environment. The role requires regular, long periods of standing, performing precision compounding tasks, keyboarding, and computer use, with occasional lifting of pharmaceutical supplies up to 30 lbs. The position requires the ability to wear required cleanroom Personal Protective Equipment (PPE), including masks, gloves, cleanroom suits, hairnets, safety goggles, and shoe covers (no make up, jewelry, fake or painted finger nails). Employees must be able to successfully complete required medical clearance for use of an Occupational Safety and Health Administration (OSHA)-compliant N95 respirator and work safely around chemicals and cleaning agents commonly used in cleanroom environments. Reasonable accommodations may be made for individuals with disabilities.