Quality Assurance & Quality Control Specialist

Position Summary

The Quality Assurance & Quality Control (QA/QC) Specialist at Hillstone Pharmacy 503A compounding facility is responsible for implementing, maintaining, and continuously improving the pharmacy's quality systems to ensure compounded preparations meet all applicable safety, efficacy, sterility, and regulatory standards. This role serves as a core member of the pharmacy's quality infrastructure, supporting USP <797> compliance, TSBP 503A licensing requirements, internal SOP governance, and nonconforming event investigations. The QA/QC Manager works closely with the Pharmacist-in-Charge (PIC), compounding personnel, and pharmacy leadership to uphold rigorous quality standards across all compounding operations.

Key Responsibilities

Quality Assurance Program Management

• Develop, implement, maintain, and continuously improve the pharmacy's Quality Assurance Program inaccordance with USP <797>, USP <795>, TSBP Chapter 291 Subchapter D, and applicable FDA guidance for 503A compounding pharmacies.
• Author, review, and revise Standard Operating Procedures (SOPs), master formulation records, and quality documentation; ensure version control, timely review cycles, and staff acknowledgment.
• Maintain the quality document control system; manage SOP libraries, batch records, deviation logs, and corrective action files.
• Conduct internal quality audits of compounding operations, environmental monitoring programs, equipment maintenance records, and personnel training documentation.
• Prepare and present quality metrics, trending data, and audit findings to pharmacy management; drive corrective and preventive action (CAPA) implementation.
• Serve as the primary internal resource for regulatory questions related to 503A compounding quality, USP compliance, and TSBP standards.
• Provide mentorship, coaching and management of the Quality Assurance/Control Control technician(s). Overall supervision of the QA/QC team including PIP plans, performance evaluations, day-to-day operations and job functions.

Quality Control & Testing

• Oversee and perform quality control testing for compounded preparations including visual inspection, pH measurement, osmolarity, and in-process checks per established specifications.
• Coordinate and review results from contracted third-party analytical laboratories for potency, sterility, endotoxin, and other beyond-use date (BUD) validation studies.
• Maintain and verify calibration, qualification, and preventive maintenance records for all critical compounding equipment (balances, HPLC, pH meters, autoclaves, refrigerators/freezers, BSCs, isolators).
• Review and approve compounding batch records, environmental monitoring results, and release documentation prior to final product release.
• Monitor and trend environmental monitoring data (EM) including viable and non-viable air and surface sampling; investigate out-of-specification (OOS) or out-of-trend (OOT) results per USP <797> requirements.

Nonconforming Event Management & CAPA

• Lead investigations of nonconforming events, product complaints, adverse reactions, and deviations; conduct root cause analysis (RCA) using structured methodologies (fishbone, 5-Why, fault tree).
• Develop and implement Corrective and Preventive Action (CAPA) plans; track completion and verify effectiveness of all corrective actions.
• Maintain the complaint and adverse event log; ensure all reportable events are escalated to the PIC and evaluated for mandatory FDA or TSBP reporting obligations.
• Communicate investigation findings and corrective actions to affected staff, prescribers, and management as appropriate and permitted.
• Ensure all nonconforming event documentation is complete, audit-ready, and retained per regulatory andpharmacy retention requirements.

Sterile Compounding & USP <797> Compliance

• Maintain and oversee the pharmacy's USP <797> compliance program including cleanroom classification, environmental monitoring schedules, personnel garbing and aseptic technique competency assessments, and gloved fingertip sampling programs.
• Coordinate and review results from cleanroom certification and recertification activities (HVAC, HEPA filter integrity, ISO classification, pressure differentials, temperature and humidity monitoring).
• Ensure all compounding personnel complete required USP <797> training, initial and annual competency assessments, and media-fill and gloved fingertip testing per current USP chapter requirements.
• Monitor and document facility conditions; investigate and escalate any environmental excursions, pressure differential failures, or HVAC anomalies.
• Support preparation and documentation for TSBP sterile compounding inspections and any FDA facility assessments.

Personnel Training & Competency

• Develop, coordinate, and document the pharmacy's QA/QC training curriculum for compounding technicians, pharmacists, and support staff covering SOPs, aseptic technique, garbing, gowning, and quality expectations.
• Conduct or coordinate initial and annual competency evaluations including written assessments, practical demonstrations, and media-fill testing.
• Maintain complete and current training files for all compounding personnel; ensure training records are audit-ready.
• Coach and mentor compounding staff on quality standards, aseptic practices, and SOP compliance; identify and address training gaps identified through audits or deviations.

Regulatory Compliance & Inspections

• Maintain current knowledge of applicable regulations including USP <795>, USP <797>, USP <800> (hazardous drugs), TSBP 503A rules, FDA Guidance for 503A Compounding Pharmacies, and relevant state Board of Pharmacy rules.
• Prepare and maintain inspection-readiness documentation including quality binders, environmental monitoring logs, calibration records, personnel training files, and SOP libraries.
• Serve as a key liaison and subject matter expert during TSBP inspections, third-party audits, and any FDA correspondence related to quality matters.
• Monitor changes in USP standards, TSBP rules, and FDA guidance; assess impact on current procedures and initiate SOP updates and staff communications as needed.
• Additional responsibilities as assigned.

Minimum Qualifications

Education

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a closely related life sciences field required.
• Pharm.D. or advanced degree in pharmaceutical sciences, quality management, or a related discipline preferred.

Licensure & Certification

• Tennessee State Board of Pharmacy (TSBP) Pharmacy Technician Registration required if performing any compounding or data entry functions within the TSBP scope of practice for technicians; Pharmacist licensure preferred.
• Certification as a Registered Pharmacy Technician (CPhT) through PTCB or ExCPT preferred.
• Completion of USP <797> or sterile compounding-specific training (e.g., CriticalPoint, PCAB accreditation training) preferred.
• ASQ Certified Quality Auditor (CQA) or equivalent quality management certification preferred.

Experience & Skills

• Minimum 2–3 years of experience in a pharmacy quality assurance, quality control, or regulatory compliance role; 503A or 503B sterile compounding pharmacy experience strongly preferred.
• Working knowledge of USP <795>, USP <797>, and USP <800> standards and their practical application in a compounding environment.
• Demonstrated experience conducting internal quality audits, nonconforming event investigations, and root cause analysis.
• Proficiency with quality documentation systems, batch record review, and document control best practices.
• Strong analytical, problem-solving, and critical thinking skills with meticulous attention to detail.
• Excellent written and verbal communication skills; ability to prepare clear quality reports and present findings to pharmacy leadership and regulatory personnel.
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook); experience with pharmacy management or quality management software preferred.

Preferred Qualifications

• Experience in a PCAB-accredited or state-licensed 503A sterile compounding pharmacy.
• Hands-on experience with environmental monitoring program management including viable and non-viable air and surface sampling, data trending, and OOS investigations.
• Familiarity with pharmacy quality software platforms.
• Experience managing third-party laboratory relationships for compounded preparation testing (potency, sterility, endotoxin, BUD studies).
• Knowledge of FDA 503B outsourcing facility quality standards and cGMP principles as applied to 503A operations.

Physical Requirements & Work Environment

• Ability to work in an ISO-classified cleanroom environment; must be able to don and doff full garbing (gown, gloves, hood, shoe covers, mask) per USP <797> requirements.
• Extended periods of standing at compounding workstations and seated desk work reviewing documentation and quality records.
• Ability to work with hazardous drugs under appropriate engineering controls and PPE per USP <800>requirements.
• Ability to lift up to 30 lbs (supplies, equipment, documentation binders).
• Work environment: sterile compounding cleanroom, ante-room, quality office, and general pharmacy administrative areas; climate-controlled with strict environmental monitoring requirements.

Supervisory Structure & Oversight

The Quality Assurance & Quality Control Manager reports directly to the Director of Pharmacy Services & Compliance. This position operates with significant professional autonomy in executing quality functions but requires close collaboration with the PIC for all regulatory decisions, product release determinations, nonconforming event escalations, and reportable adverse events. Per TSBP regulations, all compounding quality activities must be performed under pharmacist supervision, and any technician-performed functions must remain within the defined scope of practice for TSBP-registered pharmacy technicians.

Application Question(s):

• Do you have experience working in a PCAB-accredited or state-licensed 503A sterile compounding pharmacy?
• Do you have hands-on experience managing an environmental monitoring program, including viable and non-viable air and surface sampling, data trending, and OOS investigations?
• Do you have experience managing third-party laboratory relationships for compounded preparation testing, including potency, sterility, endotoxin, and BUD studies?
• Do you have knowledge of FDA 503B outsourcing facility quality standards and cGMP principles as applied to 503A operations?

Work Location: In person

Salary : $45,487 - $66,780