Aseptic Manufacturing Operator

Strive Pharmacy•Alachua, FL

10d•Onsite

About The Position

Strive Outsourcing is seeking a skilled, detail-oriented Aseptic Manufacturing Operator to prepare custom sterile compounded medications while maintaining quality, accuracy, and regulatory compliance. Under the direct supervision of operations and quality leaders, the operator performs aseptic compounding, completes required documentation, maintains GMP cleanroom standards, and supports the safe production of large-batch pharmaceuticals in accordance with Standard Operating Procedures (SOPs). This is a full-time, onsite position in Alachua, Florida, Monday through Friday on the day shift. The role includes staging batches, cleaning and setting up equipment, documenting production in batch records and logbooks, and independently assisting with compounding activities after training. The operator must follow hazardous-drug safety protocols and wear specialized PPE, including respirators and full-body protective suits, for extended periods. Medical clearance and respirator fit-testing are required before handling active pharmaceutical ingredients, and ongoing medical monitoring, including hormone-level testing, is required. Strive Pharmacy is a personalized compounding pharmacy focused on individualized patient care and partnerships with patients and providers. The company describes its workplace as collaborative and engaging, with opportunities for employees' personal and professional growth.

Requirements

High school diploma or equivalent.
At least 1 year of pharmaceutical manufacturing experience with strong aseptic technique.
Working knowledge of USP <795>, USP <797>, USP <800>, and 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 attention to detail, accuracy, and quality standards.
Ability to operate specialized equipment used in sterile compounding.
Ability to perform periods of standing up to 6 hours per shift and to twist and lift product material during the shift.
Ability to meet medical clearance requirements and pass respirator fit-testing before handling active pharmaceutical ingredients.
Willingness to comply with ongoing medical monitoring, including baseline and periodic hormone-level testing.
Ability to work onsite in Alachua, Florida, Monday through Friday on the day shift.

Nice To Haves

Technical certificates or training, an associate or bachelor's degree, or a strong scientific background.
Prior experience 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 attention to detail and experience with Good Documentation Practices.

Responsibilities

Follow proprietary formulations and established procedures to produce sterile injectable medications accurately and safely.
Perform ongoing quality checks, prepare samples for testing, and initiate investigations into deviations from established procedures.
Work with Operations Directors, Managers, and/or Supervisors and Quality Assurance teams to maintain product integrity, accuracy, and regulatory compliance.
Maintain calibration logs for scales, electronic meters, and other manufacturing equipment.
Accurately document quality procedures, production activities, and required compounding records, including batch records and logbooks.
Assist with staging batches and cleaning and setting up equipment for daily activities.
Maintain cleanroom cleanliness, organization, and compliance with established procedures.
Dispose of chemicals and waste materials according to safety protocols.
Monitor inventory, identify supply needs, report shortages to supervisors, and inspect materials for expiration or quality concerns.
Participate in audits, inspections, competency assessments, and required continuing education activities.
Maintain adherence to SOPs, cGMP requirements, and the manufacturing schedule.
Meet Right First Time metrics by reducing errors and deviations and completing corrections promptly.
Maintain aseptic gowning and media fill qualifications.
Assist independently with compounding activities after training.
Perform disinfectant and sanitation cleaning of aseptic areas for environmental control.
Follow Occupational Exposure Limits and NIOSH hazardous-drug protocols when weighing, compounding, or packaging Schedule III hormones and other potent endocrine-disrupting compounds.
Wear required specialized PPE, including respirators and full-body protective suits, and comply with medical clearance, fit-testing, and ongoing medical monitoring requirements.
Arrive on time and ready to work each day; perform other duties as directed by supervisors.

Benefits

Employer-paid healthcare coverage, effective the first day of the month following the hire date.
Free Strive compounded medications for employees with a valid patient-specific prescription from a licensed healthcare provider.
Paid time off.
Sick time.
Flexible spending account (FSA) and health savings account (HSA) options.
Parental leave.
401(k) with employer matching.
Life insurance.
Vision insurance.
Dental insurance.
Veterinary insurance.