503B Sterile Compounding Technician

Revelation Pharma LLC; Hoover (AL); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

Health care insurance (medical, dental

Vision

Life Insurance

Supplemental Insurance

PTO

401K matching

Sick leave

Job summary

Revelation Pharma LLC seeks a 503B Sterile Compounding Technician to prepare sterile pharmaceutical products in a controlled environment. You will train to work in aseptic ISO 7 rooms and ISO 5 workspaces, ensuring all admixtures meet FDA and cGMP requirements.

You will also manage inventory, maintain a clean room, and adhere to SOPs and regulatory guidelines as part of a collaborative team. Strong aseptic technique and attention to detail are essential.

Qualifications

• Must have strong aseptic technique and hand-eye coordination.
• Knowledge of cGMP, USP <797> and FDA regulations.
• Ability to work quickly and accurately under time and volume constraints.

Responsibilities

• Follow cGMP and FDA/USP guidelines in sterile compounding.
• Maintain manufacturing records and documentation per regulations.
• Operate and monitor sterile compounding equipment to ensure quality.

Skills

Aseptic technique

cGMP knowledge

Attention to detail

Sterile compounding experience

PTCB Certification

Education

High school diploma or GED

Job description

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.

Minimum qualifications:

• Active pharmacy technician registration with the State Board of Pharmacy. License must be in good standing.
• Strong aseptic technique and hand-eye coordination
• 503B Sterile compounding experience (preferred)
• 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.

Benefits:

• Health care insurance (medical, dental, vision)
• 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.