Quality Assurance Pharmacist

Job Description: Quality Assurance Pharmacist (503A Sterile Compounding Pharmacy)Overview The Quality Assurance (QA) Pharmacist plays a critical role in ensuring compliance with applicable regulations, compounding standards, and internal procedures in a 503A compounding pharmacy. This position is responsible for maintaining the integrity of compounded preparations through oversight of quality systems, documentation, and continuous improvement practices. The QA Pharmacist will work collaboratively with pharmacy staff to ensure patient safety, product quality, and regulatory compliance. Key Responsibilities • Develop, implement, and maintain QA systems in alignment with USP <795>, <797>, <800>, state board of pharmacy regulations, and other applicable standards. • Monitor, document, and investigate reported adverse events or product complaints and ensure timely reporting to appropriate regulatory bodies, and implement follow-up actions including root cause analysis, trending, and corrective measures in accordance with pharmacy policies and applicable laws. • Conduct and/or oversee routine audits of sterile and non-sterile compounding processes, facilities, equipment, and documentation. • Review and approve compounding records, batch release documents, and standard operating procedures (SOPs). • Investigate deviations, non-conformances, and out-of-specification results; lead root cause analysis and ensure appropriate corrective and preventive actions (CAPAs). • Oversee and ensure proper handling, storage, and qualification of raw materials and components. • Conduct risk assessments to evaluate and mitigate potential quality or compliance issues. • Coordinate and respond to quality-related inspections by state or federal agencies. • Maintain records in compliance with documentation requirements. • Support change control, validation, and qualification efforts related to new processes, products, or equipment Qualifications • Education: Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy from an accredited institution. • Licensure: Active pharmacist license in good standing with the Texas State Board of pharmacy(multistate licensure is a plus). • Experience: Minimum of 1-2 years of experience in sterile compounding, preferably in a 503A pharmacy, with a strong understanding of USP <797>, <795>, <800> and cGMP standards. 1+ year in a quality assurance or compliance-related role preferred. • Skills: In-depth knowledge of sterile compounding techniques, aseptic processing, and quality assurance principles. Strong analytical and problem-solving skills to investigate deviations and implement effective solutions. Excellent attention to detail and organizational skills to manage complex documentation and compliance requirements. Effective communication and training skills to educate staff and collaborate with cross-functional teams. Proficiency in pharmacy information systems and quality management software. Ability to train and mentor team members on quality systems and compliance • Physical Requirements: This role requires routine presence in cleanroom and laboratory environments. May involve standing, gowning, and working in controlled environments for extended periods. Southend Pharmacy is unable to offer visa sponsorship at this time. Candidates must be legally authorized to work in the United States without current or future sponsorship. Work Environment • The role involves working in a controlled cleanroom environment with strict adherence to gowning and aseptic procedures. • May require handling hazardous materials with appropriate safety measures. • Occasional evening, weekend, or on-call shifts may be required to support pharmacy operations or address urgent quality issues. Job Type: Full-time Pay: $100,000.00 per year Benefits: • Dental insurance • Health insurance • Paid time off Ability to Commute: • Houston, TX 77006 (Required) Work Location: In person