Quality Control Supervisor - 503A Compounding Pharmacy

HEALTHWEALTH PHARMACY•Houston, TX

16d•$31 - $37•Onsite

About The Position

Health Wealth Pharmacy is seeking an organized, detail-oriented, and experienced Quality Control Supervisor to oversee quality control processes in its 503A compounding pharmacy. The role monitors and maintains quality standards, reviews compounding documentation, verifies compliance with procedures, identifies discrepancies, and supports continuous improvement. It works closely with pharmacists, sterile compounding technicians, pharmacy operations, and leadership to help ensure compounded preparations are manufactured, documented, stored, and handled in accordance with applicable federal and state regulations, USP standards, and internal quality procedures. The supervisor oversees daily quality control activities and reviews batch records, ingredient documentation, Certificates of Analysis (COAs), beyond-use dating, medication labels, sterile compounding practices, environmental monitoring records, equipment documentation, and quality investigations. The position supports audits and inspection readiness, SOP development and implementation, corrective and preventive actions, employee training, and quality improvement initiatives. It provides guidance to personnel involved in quality control and escalates significant concerns to the Pharmacist-in-Charge. The position supports pharmacist oversight and does not independently perform pharmacist-only clinical verification, dispensing authorization, or final product release unless separately licensed and authorized.

Requirements

At least 3 years of quality assurance or quality control experience, preferably in a 503A compounding pharmacy.
At least 1 year of supervisory or team leadership experience.
Hands-on experience with batch records, COAs, beyond-use dating (BUD), and quality documentation.
Working knowledge of USP <795>, USP <797>, and USP <800>, as applicable.
Experience conducting audits, investigating deviations, and implementing corrective and preventive actions (CAPAs).
Familiarity with FDA, DEA, and Texas State Board of Pharmacy requirements relevant to the position.
Exceptional attention to detail and commitment to accuracy.
Strong knowledge of quality control principles and documentation requirements.
Ability to recognize potential medication, formulation, labeling, and documentation errors.
Strong analytical, critical-thinking, organizational, recordkeeping, leadership, coaching, and problem-solving skills.
Ability to prioritize multiple responsibilities in a high-volume environment and communicate quality findings effectively.
Ability to maintain confidentiality, work collaboratively across pharmacy departments, and exercise sound judgment when escalating concerns.
Commitment to regulatory compliance, quality assurance, and patient safety.
Ability to stand or sit for extended periods, work in controlled pharmacy and compounding environments, wear required PPE and garb in designated areas, and perform repetitive documentation and inspection tasks accurately.
Ability to lift and move pharmacy supplies and materials consistent with job requirements, with reasonable accommodation when applicable.

Nice To Haves

Previous experience in a 503A compounding pharmacy.
Experience in sterile compounding quality control or quality assurance.
Familiarity with USP <797>, USP <795>, and USP <800>.
Experience reviewing batch records and master formulation records.
Experience reviewing Certificates of Analysis (COAs).
Knowledge of GLP-1 compounded medications, including tirzepatide and semaglutide formulations.
Experience with beyond-use dating, medication labeling, and lot traceability.
Familiarity with environmental monitoring and controlled pharmacy environments.
Experience participating in regulatory inspections or internal quality audits.
Experience investigating quality deviations and implementing corrective actions.
Previous supervisory or team leadership experience.
Experience developing or implementing pharmacy SOPs and quality improvement procedures.

Responsibilities

Oversee daily quality control activities and monitor adherence to quality procedures, SOPs, and applicable regulatory requirements.
Review compounding processes and monitor product quality through compounding, verification, storage, and fulfillment.
Ensure quality control checks are completed and documented; identify, communicate, and escalate concerns affecting medication safety, product integrity, or compliance.
Coordinate with pharmacists and pharmacy leadership to resolve quality control issues and maintain quality management systems.
Review compounding batch records for accuracy, completeness, and procedural compliance, including ingredients, lot numbers, quantities, calculations, preparation dates, and beyond-use dates.
Identify documentation gaps and errors, coordinate corrections, and maintain organized, traceable quality records.
Assist with maintaining master formulation records and related quality documentation.
Review and maintain applicable COAs and supporting documentation; verify consistency with lot numbers and formulation records and escalate missing or questionable documentation.
Review beyond-use date documentation and verify dates, lot numbers, and storage requirements; monitor labeling and packaging quality procedures.
Assist with investigating labeling errors and ensure concerns are escalated before affected preparations are dispensed.
Monitor compliance with sterile compounding procedures and USP <797>; support oversight of aseptic technique, garbing, hand hygiene, cleaning, sanitation, and contamination control.
Review environmental monitoring and cleaning records, equipment maintenance, calibration, certification, and related documentation.
Assist with reviewing sterile compounding personnel training and competency records and support compliance with USP <795> and USP <800> where applicable.
Investigate or assist with investigating compounding discrepancies, documentation errors, labeling concerns, and other quality incidents; document findings and support root cause analysis.
Assist in developing and implementing corrective and preventive actions (CAPA), monitor completion and effectiveness, and maintain investigation records.
Conduct routine internal quality reviews and audits, identify deficiencies and risks, and help prepare records for inspections and audits.
Support regulatory compliance, inspection readiness, and corrective action plans following inspections or identified deficiencies.
Assist with developing, reviewing, updating, and implementing quality control SOPs; monitor employee adherence to approved procedures.
Recommend and support improvements to documentation accuracy, workflow consistency, and quality control efficiency; monitor quality trends and communicate findings.
Provide guidance, training, and support to quality control personnel; monitor assigned work, identify training needs, and assist with onboarding and quality training.
Collaborate across pharmacy teams and promote accountability, accuracy, and patient safety; escalate operational, staffing, and compliance concerns as appropriate.