Sterile Compounding Technician - DP in Mesa, Arizona at Revelation Pharma LLC

Job Summary:

The Sterile Compounding Technician is responsible for staging and preparing all components for drug production in a cleanroom environment. Technicians may also engage in compounding low to high-risk sterile products and filling patient orders, as authorized.

Job Activities and Responsibilities: The responsibilities listed below are subject to change.

• Sterile compounder must have knowledge of United States Pharmacopeia General Chapter <797> Pharmaceutical Compounding – Sterile Preparations and follow policies and Standard Operating Procedures.
• Daily prepare and verify all components for compounding staff according to a determined production schedule.
• Responsible for device and or equipment sterilization processes under pharmacist supervision.
• Compounding may include sterile to sterile transfers, packaging, and labeling of one or more drugs. 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.
• Support daily, weekly, and monthly cleaning of the environment with appropriate disinfectants and techniques.
• Initial and ongoing competency evaluation must be successfully completed as required in the policies and procedures Technicians work under the supervision of a pharmacist.
• Sterile compounding includes but is not limited to injections, ophthalmic and inhalation solutions.

Minimum qualifications:

• Must be registered with the State Board of Pharmacy.
• Strong aseptic technique and hand-eye coordination
• 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.

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

Roles and Responsibilities of the Designated Person

At RPC, the Designated Person (DP) plays a critical role in ensuring the quality of the compounded medications that we produce, along with promoting safety and competency among compounding personnel. Because the DP role could be fulfilled by personnel with different backgrounds and credentials, this is not a role that is defined as an official job function; rather it is considered an addition to a current role.

The responsibilities of the DP will vary at each RPC location based on the scope of compounded preparations being produced. Below is a summary of potential expectations:

Pharmacies producing nonsterile preparations (ref. USP <795>):

• Ensure that compounding personnel are properly trained and competent in compounding nonsterile preparations.
• Oversee the compounding process to ensure that it follows established procedures and meets quality standards.
• Ensure that appropriate equipment and facilities are used for compounding nonsterile preparations.
• Monitor the quality and integrity of ingredients used in compounding.
• Implement and oversee a system for labeling, storage, and expiration dating of compounded nonsterile preparations.
• Maintain records of compounded preparations, including formulation and compounding details.
• Ensure that compounding personnel adhere to safety measures and use appropriate personal protective equipment (PPE).

Pharmacies producing sterile preparations (ref. USP <797>):

• Ensure that compounding personnel are properly trained and competent in aseptic compounding techniques.
• Oversee the preparation of sterile compounded medications and ensure compliance with aseptic processing requirements.
• Verify the proper cleaning and disinfection of the compounding area and equipment.
• Establish and enforce policies and procedures for hand hygiene, garbing, and environmental monitoring.
• Maintain a compounding quality assurance program, including regular testing of finished preparations.
• Develop and implement a beyond-use dating (BUD) system for sterile compounded preparations.
• Conduct ongoing training and competency assessments for compounding personnel.
• Ensure that any deviations or errors in the compounding process are documented and addressed promptly.

Pharmacies handling hazardous preparations (ref. USP <800>):

• Ensure compliance with the requirements for handling hazardous drugs as outlined in USP Chapter 800.
• Establish and maintain a hazardous drug handling program, including risk assessment and policies for personnel protection.
• Implement measures to minimize exposure to hazardous drugs during compounding, administration, and disposal.
• Oversee the proper use of engineering controls, such as biological safety cabinets, when compounding hazardous drugs.
• Ensure that compounding personnel are trained in the safe handling of hazardous drugs and the use of PPE.
• Monitor and assess the effectiveness of the facility's containment strategies.
• Develop a hazardous drug spill management plan and ensure that personnel are trained in its implementation.
• Maintain records related to the handling of hazardous drugs and personnel training.

RPC DPs work as an extension of corporate Quality Assurance (QA), thus this role is treated as a team-based approach to ensuring quality in all RPC facilities. The local DP will receive materials, guidance, and support to complete all tasks. While still reporting to the local General Manager, DP’s will have an added level of communication with QA to achieve objectives.

RPC DPs need to possess the following qualities:

• Commitment to continually learning – quality assurance is never fully achieved, rather it is a commitment to continue improving by seeing opportunities to advance and learning from mistakes.
• Attention to detail.
• Passion for improving operations at the pharmacy level.
• Drive to be an educator and provide constructive feedback to improve performance.
• Willing to call out deviations from quality matters when necessary.