HEALTHWEALTH PHARMACY→
Quality Control Supervisor - 503A… at HEALTHWEALTH… · Houston
Skills
Job Description
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Company: Health Wealth Pharmacy, LLC Department: Pharmacy Operations / Quality Assurance Reports To: Pharmacist-in-Charge / Director of Pharmacy Employment Type: Full-Time Location: Houston, TX (On-Site)
Position Summary
Health Wealth Pharmacy is seeking a highly organized, detail-oriented, and experienced Quality Control Supervisor to oversee quality control processes within our 503A compounding pharmacy.
The Quality Control Supervisor is responsible for monitoring and maintaining quality standards, reviewing compounding documentation, verifying compliance with established procedures, identifying discrepancies, and supporting continuous improvement initiatives.
This position works closely with pharmacists, sterile compounding technicians, pharmacy operations, and leadership to ensure that compounded preparations are manufactured, documented, stored, and handled in accordance with applicable federal and state regulations, USP standards, and internal quality procedures.
The ideal candidate has experience in a 503A compounding pharmacy, strong knowledge of sterile compounding quality requirements, excellent documentation skills, and the ability to oversee quality control activities in a fast-paced pharmacy environment.
Essential Duties and Responsibilities
Quality Control Oversight
- Oversee daily quality control activities within the compounding pharmacy.
- Monitor adherence to established quality control procedures, standard operating procedures (SOPs), and applicable regulatory requirements.
- Review compounding processes to identify potential quality concerns, procedural 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.
Batch Record Review and Documentation
- 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.
Certificate of Analysis (COA) and Ingredient Verification
- 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.
Beyond-Use Dating and Label Verification
- 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.
Sterile Compounding Quality Assurance
- 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.
Quality Investigations and Corrective Actions
- 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.
Regulatory Compliance and Inspection Readiness
- 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.
Standard Operating Procedures and Quality Improvement
- 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 improvement initiatives and employee education.
- Monitor quality performance trends and communicate findings to leadership.
Team Supervision and 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.
Minimum Qualifications
- 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.
Preferred Qualifications
- 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.
Knowledge, Skills, and Abilities
- 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 and critical-thinking abilities.
- Ability to prioritize multiple responsibilities in a high-volume environment.
- Excellent organizational and recordkeeping skills.
- Ability to identify quality concerns and communicate findings effectively.
- Strong leadership, coaching, and problem-solving skills.
- Ability to maintain confidentiality and handle sensitive pharmacy information.
- Ability to work collaboratively across pharmacy departments.
- Commitment to regulatory compliance, quality assurance, and patient safety.
- Ability to exercise sound judgment and escalate concerns appropriately.
Physical Requirements
- Ability to stand or sit for extended periods.
- Ability to work within controlled pharmacy and compounding environments.
- Ability to wear required personal protective equipment and garb when entering designated areas.
- Ability to perform repetitive documentation and inspection tasks requiring accuracy and attention to detail.
- Ability to lift and move pharmacy supplies and materials consistent with job requirements, with reasonable accommodation when applicable.
Performance Expectations
The Quality Control Supervisor is expected to maintain a high standard of accuracy, organization, accountability, and regulatory compliance throughout pharmacy operations.
The supervisor must ensure that assigned quality control reviews are completed thoroughly and that discrepancies involving compounding documentation, labeling, lot numbers, beyond-use dating, or product quality are promptly identified, documented, and escalated.
The position requires consistent communication with pharmacy leadership, timely follow-up on quality concerns, and a proactive approach to preventing errors and improving quality control procedures.
The Quality Control Supervisor supports pharmacist oversight and does not independently perform pharmacist-only clinical verification, dispensing authorization, or final product release unless separately licensed and authorized to perform those functions.
About Us
HealthWealth Pharmacy is a trusted pharmacy provider based in Houston, Texas, serving patients across multiple states. We are committed to quality, integrity, and patient-centered care. Our patients and healthcare partners rely on us for accurate, safe, and timely pharmacy services that make a meaningful difference in their health and well-being.
We foster a supportive and collaborative workplace where employees are empowered to grow professionally, contribute to continuous improvement, and make a positive impact on patient care every day.
Compensation: $31.00 - $37.00 per hour