503B Sterile Compounding Technician

Revelation Pharma; Hoover (AL); On-site; USD 32,000 - 41,000; Full time

Benefits offered by this job

Life Insurance

Supplemental Insurance

PTO

401K matching

Sick leave

Job summary

Revelation Pharma in Hoover, AL is seeking a 503B Sterile Compounding Technician to prepare and admixture sterile products in ISO clean rooms, following FDA, cGMP, and USP <797> standards under pharmacist supervision.

This full-time role requires active pharmacy technician registration, high school diploma or GED, and strong aseptic technique. You will maintain records, operate equipment, monitor inventory, and complete batch validations.

Qualifications

• Active pharmacy technician registration with the State Board of Pharmacy.
• PTCB Certification (preferred).
• High school diploma or GED.
• Ability to work quickly and accurately under time and volume constraints.

Responsibilities

• Sterile compounder must have knowledge of cGMP, USP <797>, FDA regulations, and follow SOPs.
• Maintain manufacturing records and complete documentation per guidelines.
• Operate and monitor sterile compounding equipment ensuring quality.
• Weigh and mix activities associated with sterile medication compounding.
• Prepare records and monitor results for quality assurance testing.
• Sterilization processes under pharmacist supervision.
• Close attention to detail; ensures potency, quality, purity, sterility.
• Monitor inventory levels and re-order of low inventory or expiring chemicals.
• Verify materials for use in batch compounding.
• Support daily, weekly, and monthly cleaning of the environment.
• End of batch reconciliation and count verification.
• Aseptic technique competency evaluation as required.
• Complete product validations and media fill verifications.
• Other duties as assigned by department or pharmacy manager.

Skills

Aseptic technique

Hand-eye coordination

Attention to detail

Time management

Education

High school diploma or GED

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time 30+ Individual Eagle Pharma Outsourcing LLC, Hoover, AL, US

Salary Range: $23.00 To $30.00 Hourly

Job Summary:

The 503B Sterile Compounding Technician is responsible for the preparation and admixture of sterile pharmaceutical products in a highly controlled, regulated environment. This technician will undergo a stringent training program to become qualified to work in aseptic environment inside ISO 7 rooms and ISO 5 workspaces, ensuring admixtures are completed properly per FDA and cGMP requirements. The 503B Sterile Compounding Technician is also responsible for managing product inventory and supplies and is expected to maintain a highly organized clean room. This technician will work with the team to ensure compliance to standard operating procedures and regulatory requirements.

Job Activities and Responsibilities

The responsibilities listed below are subject to change.

• Sterile compounder must have knowledge of current Good Manufacturing Practices (cGMP), United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, FDA regulations, and follow policies and Standard Operating Procedures.
• Maintain manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
• Operate and monitor technical, computerized compounding/filling equipment ensuring quality standards are maintained.
• Responsible for weighing and mixing activities associated with the compounding of sterile medications.
• Prepare records and monitor results for pharmaceutical quality assurance testing.
• Responsible for device and/or equipment sterilization processes under pharmacist supervision.
• Position requires close attention to detail. Standards for potency, quality, purity, integrity, sterility, and endotoxin content must be consistently met.
• Monitor inventory levels for re-order of low inventory or expiring chemicals, compounds, devices and/or containers.
• Verify materials for use in batch compounding.
• Support daily, weekly, and monthly cleaning of the environment with appropriate disinfectants and techniques.
• Complete end of batch reconciliation and count verification.
• Initial and ongoing aseptic technique competency evaluation must be successfully completed as required in the policies and procedures.
• Successful completion all product validations and advances complex media fill verifications.
• Other duties as assigned by department or pharmacy manager.
• Active pharmacy technician registration with the State Board of Pharmacy. License must be in good standing.
• Strong aseptic technique and hand-eye coordination
• PTCB Certification (preferred)
• High school diploma or general education degree (GED) required
• Ability to work quickly and accurately under time and volume constraints

Physical requirements:

• Proficient in using a computer and related equipment, including printers and fax machines.
• Ability to sit or stand for extended periods.
• Effective communication skills via telephone and email.
• Capable of lifting up to 40 pounds as needed.
• 20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.
• Life Insurance
• Supplemental Insurance
• PTO
• 401K matching
• Sick leave

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.