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.
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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.
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Maintain manufacturing records and completes all required documentation in compliance with cGMP, FDA, USP and pharmacy state board regulatory guidelines.
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Operate and monitor technical, computerized compounding/filling equipment ensuring quality standards are maintained.
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Responsible for weighing and mixing activities associated with the compounding of sterile medications.
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Prepare records and monitor results for pharmaceutical quality assurance testing.
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Responsible for device and/or equipment sterilization processes under pharmacist supervision.
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Position requires close attention to detail. Standards for potency, quality, purity, integrity, sterility, and endotoxin content must be consistently met.
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Monitor inventory levels for re-order of low inventory or expiring chemicals, compounds, devices and/or containers.
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Verify materials for use in batch compounding.
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Support daily, weekly, and monthly cleaning of the environment with appropriate disinfectants and techniques.
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Complete end of batch reconciliation and count verification.
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Initial and ongoing aseptic technique competency evaluation must be successfully completed as required in the policies and procedures.
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Successful completion all product validations and advances complex media fill verifications.
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Other duties as assigned by department or pharmacy manager.
Minimum qualifications:
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Active pharmacy technician registration with the State Board of Pharmacy. License must be in good standing.
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Strong aseptic technique and hand-eye coordination
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503B Sterile compounding experience (preferred)
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PTCB Certification (preferred)
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High school diploma or general education degree (GED) required
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Ability to work quickly and accurately under time and volume constraints
Physical requirements:
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Proficient in using a computer and related equipment, including printers and fax machines.
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Ability to sit or stand for extended periods.
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Effective communication skills via telephone and email.
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Capable of lifting up to 40 pounds as needed.
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20/20 vision (with or without corrective aids) required for visual inspection of drug products, in accordance with legal requirements.
Benefits:
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Health care insurance (medical, dental, vision)
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Life Insurance
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Supplemental Insurance
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PTO
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401K matching
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Sick leave
Revelation Pharma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
