Quality Assurance & Compliance Manager

Job description

Quality Assurance Manager/Compliance Manager will use their skills to ensure continued compliance with all state and federal regulations, and that the medications that we produce are of the highest level of quality and safety.

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

• Responsible for all daily quality operations within the facility. Ensures compliance with procedures, governing regulations, and addresses non-compliance issues.
• Conduct root cause analysis for compounding errors and in-process errors generated at the facility during all phases of the compounding process.
• Monitor changes to state, FDA, and USP 800/797/795 regulations and work with legal team, management, and staff on implementing any regulatory changes.
• Prepare and submit yearly State Board of Pharmacy License Renewals for 44 states.
• Submit Daily/Weekly reports to State Boards of Pharmacy, listing prescriptions dispensed.
• Oversight of all work performed by cleanroom staff to ensure that all Standard Operating Procedures (SOP's) are followed and that all quality/safety related tasks are properly documented.
• Ensure that each batch of sterile drug has been subjected to the required testing procedures, and is within proper specifications, before being released for patient use.
• Apply techniques of Continuous Quality Improvement to the medications that we produce.
• Reviewing correspondence from prescription insurance plans that we participate with, documenting and notifying staff of any rule changes.
• Review audits from prescription insurance plans that we participate with.

Qualifications:

• Excellent organizational skills
• Strong attention to detail
• Strong work ethic
• Basic math skills, including fractions, percentages, ratios, and proportions.
• Strong writing and communication skills
• Professional and friendly attitude with excellent interpersonal skills
• Ability to learn new skills and information quickly.

Education & Experience:

• Bachelor's degree in one of the following broad areas (science, medicine, business, or law)
• Previous work experience in Quality Assurance or Compliance preferred but not required.
• Knowledge of sterile procedures/aseptic technique preferred but not required.
• Training in Continuous Quality Improvement, or similar quality improvement techniques, preferred but not required.
• Experience with reading and interpreting legal contracts, laws, and regulations preferred but not required.

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