Compounding Quality Assurance Pharmacist - Night Shift
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
Requirements
- 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 <797>, <795>, <800>, and cGMP standards
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