Quality Assurance and Compliance Specialist

Role Summary

The primary responsibility is to assist the Quality Manager with ensuring that all preparations, products, and processes are current and compliant with United States Pharmacopeia (USP) standards, Pharmacy Compounding Accreditation Board (PCAB) standards, State(s) Board of Pharmacy Standards, and FDA guidance and regulations.

Job Activities and Responsibilities

• Demonstrate competency and knowledge of USP 795, 797, 797, and other applicable USP chapters.
• Maintain and continuously expand upon subject matter knowledge and expertise related to pharmacy standards, guidelines, rules, and regulations.
• Work closely with the Quality Assurance and Compliance Manager and other departmental managers to track, monitor, and report findings on all aspects of quality and compliance relating to pharmacy services including non-sterile, sterile, and allergy compounding.
• Strive to achieve team buy-in as it relates to quality and compliance.
• Support Quality Team members at Innovation Compounding and other sister pharmacies as needed and determined by management.
• Assist with inspections, investigations, and audits.
• Validate, audit, analyze, trend, and document pharmacy vendor performance.
• Track, monitor, report, and assist with personnel and operational compliance including, but not limited to environmental monitoring; process validations; competency assessments; various staff trainings; destruction/disposal of drugs, materials, and other pharmacy-related items; equipment and instrumentation validation, calibration, certification, maintenance, and repair; and preparation release testing.
• Assist with new hire orientation related to quality and compliance.
• Assist in quality and compliance efforts as needed by the Quality Assurance and Compliance Manager and other departmental managers on any other activities to the benefit of the pharmacy.

Qualifications and Education Requirements

• Bachelor of Science in related field.
• Willingness to be licensed by applicable Board(s) of Pharmacy, certified by the Pharmacy Technician Certification Board, and certified in basic and aseptic certification.
• Must have HIPAA certification.
• Previous experience as a quality specialist preferred.

Physical requirements

• Ability to use a computer and computer-related equipment, printer/fax machine.
• Communicate by telephone and email.
• Lift to forty (40) pounds.

Benefits

• Health care insurance (medical, dental, vision).
• Life Insurance.
• Supplemental Insurance.
• PTO.
• 401K matching.
• Sick leave.

Company Information

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