Senior Quality Control Leader - 503A Compounding

HEALTHWEALTH PHARMACY; Houston (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Health Wealth Pharmacy in Houston, TX is seeking a Quality Control Supervisor to oversee quality control in our 503A compounding operations, ensuring compliance with USP standards and regulatory requirements.

The successful candidate will lead QC activities, review batch records and COAs, and collaborate with pharmacists and leadership to drive continuous improvement while maintaining patient safety.

Qualifications

• 3+ years 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 CAPAs.
• Familiarity with FDA, DEA, and Texas State Board of Pharmacy requirements relevant to the position.

Responsibilities

• Oversee daily quality control activities within the compounding pharmacy.
• Monitor adherence to established QC procedures, SOPs, and regulatory requirements.
• Review compounding processes to identify potential quality concerns, deviations, and opportunities for improvement.
• Ensure appropriate quality control checks are completed and documented.
• Monitor product quality throughout the compounding, verification, storage, and fulfillment processes.
• Identify and escalate quality concerns that may affect medication safety, product integrity, or regulatory compliance.
• Coordinate with pharmacists and pharmacy leadership to resolve quality control issues.
• Support the implementation and maintenance of effective quality management systems.
• Review compounding batch records for accuracy, completeness, and compliance with established procedures.
• Verify documentation of ingredients, lot numbers, quantities, calculations, preparation dates, and beyond-use dates.
• Ensure batch records accurately reflect the compounding activities performed.
• Identify missing information, inconsistencies, and documentation errors.
• Coordinate corrections and follow-up documentation with appropriate personnel.
• Maintain organized and traceable quality control records.
• Ensure compounding documentation is completed according to company policies and applicable regulatory requirements.
• Assist with maintaining master formulation records and related quality documentation.
• Review and maintain Certificates of Analysis (COAs) for applicable ingredients and compounded preparations.
• Verify that required COAs and supporting quality documentation are available and appropriately reviewed before materials or preparations are used or released, as applicable.
• Confirm consistency between COAs, lot numbers, formulation records, and other supporting documentation.
• Track ingredient and formulation lot numbers to maintain traceability.
• Identify discrepancies involving ingredient documentation, specifications, or testing results.
• Escalate missing, incomplete, or questionable COAs to the pharmacist and appropriate pharmacy leadership.
• Assist with maintaining organized COA records for inspections and internal audits.
• Review beyond-use date (BUD) documentation for consistency with approved formulations and applicable standards.
• Verify that compounding dates, BUDs, lot numbers, and storage requirements are accurately documented.
• Identify discrepancies between batch records, supporting documentation, and medication labels.
• Monitor quality control procedures related to medication labeling and packaging.
• Assist with investigating labeling errors and implementing corrective measures.
• Ensure identified labeling or dating concerns are escalated before affected preparations are dispensed.
• Monitor compliance with applicable sterile compounding procedures and USP <797> requirements.
• Support quality oversight of aseptic techniques, garbing, hand hygiene, cleaning, sanitation, and contamination-control practices.
• Review required environmental monitoring records and cleaning documentation.
• Monitor completion of equipment maintenance, calibration, certification, and related quality documentation.
• Identify potential contamination risks and procedural deficiencies.
• Assist with reviewing sterile compounding personnel training and competency records.
• Coordinate with pharmacy leadership to address sterile compounding quality concerns.
• Support compliance with USP <795> and USP <800> where applicable.
• Assist with investigating compounding discrepancies, documentation errors, labeling concerns, and other quality-related incidents.
• Document quality control findings and communicate concerns to appropriate personnel.
• Support root cause analysis of quality deviations and recurring issues.
• Assist with developing and implementing corrective and preventive actions (CAPA).
• Monitor corrective action completion and effectiveness.
• Maintain accurate records of quality investigations and resolutions.
• Identify recurring quality issues and recommend process improvements.
• Escalate significant quality concerns promptly to the Pharmacist-in-Charge.
• Support compliance with applicable federal and state pharmacy regulations and Board of Pharmacy requirements.
• Assist with maintaining compliance with applicable USP standards.
• Conduct routine internal quality control reviews and audits.
• Identify documentation deficiencies and compliance risks.
• Assist with preparing quality control records for regulatory inspections and internal audits.
• Support corrective action plans following inspections or identified deficiencies.
• Maintain awareness of changes in pharmacy regulations, quality standards, and company procedures.
• Work with pharmacy leadership to maintain inspection readiness.
• Assist with developing, reviewing, updating, and implementing quality control SOPs.
• Monitor employee adherence to approved quality procedures.
• Identify opportunities to improve documentation accuracy, quality control efficiency, and workflow consistency.
• Recommend improvements to reduce errors and strengthen compliance.
• Support implementation of new quality control processes.
• Assist with quality control initiatives and employee education.
• Monitor quality performance trends and communicate findings to leadership.
• Provide guidance, training, and support to personnel involved in quality control activities.
• Monitor completion and accuracy of assigned quality control responsibilities.
• Reinforce compliance with established policies and procedures.
• Identify training needs and recommend additional employee education.
• Assist with onboarding and quality training for new employees.
• Collaborate with pharmacists, compounding technicians, fulfillment personnel, and pharmacy leadership.
• Promote accountability, attention to detail, accuracy, and patient safety.
• Escalate operational, staffing, and compliance concerns to pharmacy leadership as appropriate.

Skills

Quality Assurance

Quality Control

Supervisory

Batch Records

COAs

BUD

USP 797

USP 795

USP 800

Audits

CAPA

FDA/DEA knowledge

Job description

Health Wealth Pharmacy in Houston, TX is seeking a Quality Control Supervisor to oversee quality control in our 503A compounding operations, ensuring compliance with USP standards and regulatory requirements.

The successful candidate will lead QC activities, review batch records and COAs, and collaborate with pharmacists and leadership to drive continuous improvement while maintaining patient safety.