Compounding Quality Assurance Pharmacist

Pay
: $120,000+/annually

Start
: ASAP

Type
:
Direct Hire (Full benefits package including medical, vision, dental, 401(k) with company match, PTO, Flex days, holidays, and more!)

Location
:
Houston, Texas (77086)

Dress Code
:
Business Professional

• Education: 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
• Experience: Minimum of 1-2 years of experience in sterile compounding (preferably in a 503A pharmacy) with strong knowledge of USP , , , and cGMP standards

• Develop, implement, and maintain QA systems in alignment with USP , , , 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