Aseptic Manufacturing Operator

Strive Compounding Pharmacy; Florida; Vor Ort; USD 42.000 - 65.000; Vollzeit

Benefits dieser Stelle

Employer-paid healthcare coverage

Paid time off

401(k) with employer matching

Life insurance

Vision and dental insurance

Sick time

FSA and HSA options

Parental leave

Zusammenfassung

Strive Compounding Pharmacy is seeking an Aseptic Manufacturing Operator for our Alachua, FL site. This full-time role involves preparing sterile compounded medications under GMP, with a focus on quality, accuracy, and regulatory compliance.

You will work under supervision of operations and quality leaders, performing aseptic processes, documentation, and maintaining cleanroom standards in a fast-paced environment.

Qualifikationen

• High school diploma or equivalent.
• Minimum of 1 year of pharmaceutical manufacturing experience with strong aseptic technique.
• Working knowledge of USP, USP, and FDA cGMP guidelines.
• Strong understanding of pharmaceutical calculations, terminology, aseptic technique, and sterile compounding processes.
• Able to work efficiently in a fast-paced environment with attention to detail.

Aufgaben

• Sterile Manufacturing: follow procedures to produce sterile injectable medications.
• Quality Control & Documentation: perform quality checks, prepare samples, investigate deviations.
• Collaboration: work with Operations Directors, Managers, and QA teams to maintain compliance.
• Equipment Documentation: maintain calibration logs and document quality procedures.
• Cleanroom Maintenance: keep cleanroom orderly and compliant; dispose of chemicals safely.
• Inventory Management: monitor stock, report shortages, inspect materials for quality.
• Compliance & Continuous Improvement: participate in audits and trainings.
• Attendance and Punctuality: be on time and ready to work.

Kenntnisse

Aseptic technique

GMP compliance

Quality documentation

Attention to detail

Fast-paced work

Ausbildung

High school diploma

Pharmaceutical manufacturing certificate

Tools

Sterile compounding equipment

Jobbeschreibung

Strive Pharmacy is a personalized compounding pharmacy built on a simple conviction: medicine should fit the patient, not the other way around. We started Strive because we believed the pharmaceutical industry was overdue for a more human approach—one that prioritizes individualized care, clinical nuance, and genuine partnership with patients and providers.

Mission

Strive exists to disrupt an industry long overdue for a more personal approach to care. We put the human element at the center of everything: every formulation, every patient interaction, every provider partnership. We're not just a compounding pharmacy. We're a team on a mission to change what personalized healthcare looks and feels like.

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), USP, 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 work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities. This role also requires the following:

• Must adhere to strict Occupational Exposure Limits (OELs) and NIOSH hazardous drug protocols when weighing, compounding, or packaging Schedule III hormones and other potent endocrine-disrupting compounds.
• Required to wear specialized PPE, including respirators and full-body protective suits, for extended periods. Candidates must be medically cleared to wear a respirator and pass standard fit-testing prior to handling active pharmaceutical ingredients.
• Willingness to comply with ongoing medical monitoring, including baseline and periodic hormone level testing as part of our commitment to employee health and workplace safety.

At Strive, the work is real and the impact is direct. Every role here contributes to a patient experience that's more personal, more attentive, and more human than what most people have come to expect from a pharmacy.

Benefits/ Perks

• Employer-paid healthcare coverage, effective the 1st day of the following month of your hire date
• Free Strive compounded medications for employees based on a valid patient-specific prescription from a licensed healthcare provider
• Paid time off
• Sick time
• FSA and HSA options
• Parental leave
• 401(k) with employer matching
• Life insurance
• Vision and dental insurance
• Veterinary insurance

Culture

Culture isn't an afterthought at Strive. It's something we actively build. We foster a collaborative, engaging workplace where employees have opportunities to connect, celebrate, and build meaningful relationships with their colleagues. We're committed to supporting the personal and professional growth of every employee, both inside and outside the workplace.

EEO

Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.