Quality Assurance and Compliance Specialist

Revelation Pharma LLC•Kennesaw, GA

About The Position

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. Prepare audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans. Host and/or assist departments in preparing for external inspections. Assist with new/renewal applications for accreditation, licensure, certification, registration Initiate Quality Incident Reports after identifying errors and quarantine products as needed. Assist with the investigation of Quality Incident Reports within the scope of his/her knowledge as needed. Analyze data, identify trends and report findings to management. Ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies. 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. Perform other related duties as assigned or requested. 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.

Requirements

Bachelor of Science degree and 5-7+ years of relevant experience within the Quality Assurance, Compliance
Willingness to be licensed by applicable Board(s) of Pharmacy, certified by the Pharmacy Technician Certification Board, and certified in basic and aseptic certification.
Skilled in building and maintaining relationships across multiple departments, with strong communication and interpersonal abilities
Strong communication skills, both oral and written; ability to provide guidance and advice within area of expertise.
Skilled in data analysis using Excel and Google Sheets, with general proficiency across Microsoft Office and Google Workspace applications.
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.

Responsibilities

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.
Prepare audit tools, conduct internal audits, submit audit report and perform follow up on related corrective action plans.
Host and/or assist departments in preparing for external inspections.
Assist with new/renewal applications for accreditation, licensure, certification, registration
Initiate Quality Incident Reports after identifying errors and quarantine products as needed.
Assist with the investigation of Quality Incident Reports within the scope of his/her knowledge as needed.
Analyze data, identify trends and report findings to management.
Ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies.
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.
Perform other related duties as assigned or requested.
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.