Quality Assurance and Compliance Specialist

Job Description

Job Description

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 : The responsibilities listed below are subject to change.

Quality Specialist shall have a full understanding of and follow all Standard Operating Procedures. Must demonstrate competency and knowledge of USP 795, 797, 800, and other applicable USP chapters. Must maintain and continuously expand upon subject matter knowledge and expertise related to pharmacy standards, guidelines, rules, and regulations. Specialist will 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. Must strive to achieve team buy-in as it relates to quality and compliance. Position requires strong attention to detail. Standards for accuracy and timeliness shall be consistently met. Secondary responsibilities include supporting Quality Team members at Innovation Compounding and other sister pharmacies as needed and determined by management. Tertiary responsibilities may relate to pharmacy technician duties to support other departments as needed.

Further responsibilities of the Quality Specialist include:

• Ensuring the Standard Operating Procedures (SOPs) are continuously harmonized with all regulatory, accreditation, and FDA requirements.
• Maintaining the pharmacy's compliance with SOPs, USP standards, PCAB standards, regulatory requirements, and best practices derived from FDA guidance and regulations.
• Reviewing new, potential, and/or updated standards, guidelines, rules, and regulations through published literature, conferences/educational events, and/or other available resources as determined by management.
• Capturing, tracking, trending, analyzing, and documenting data and metrics related to quality events including, but not limited to, variances, deviations, nonconformances, drug recalls, and employee incidents.
• Assisting with inspections, investigations, and audits.
• Validating, auditing, analyzing, trending, and documenting pharmacy vendor performance.
• Tracking, monitoring, reporting, and assisting 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.
• Assisting with new hire orientation related to quality and compliance.

Account Management Duties

• Assisting with research and development (R&D) on formulations, materials, supplies, and processes.
• Completing and submitting approved pharmacy-related applications, forms, and reports.
• Processing Prescription Drug Monitoring Program (PDMP) reports.
• Providing quality-related reports and outcomes to Quality Assurance and Compliance Manager for continuous performance improvement.
• Assisting 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.
• All other duties assigned by management.

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

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