259364 - Compounding Quality Assurance Pharmacist

Medix™

Houston (TX)

On-site

USD 120,000 - 144,000

Full time

8 days ago

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Job summary

Medix is seeking a Compounding Quality Assurance Pharmacist on the night shift in Houston, TX. The role focuses on developing, implementing, and maintaining QA systems in line with USP standards and state regulations, ensuring accurate documentation and compliance across sterile and non-sterile processes.

The ideal candidate has a PharmD or PharmD-equivalent, a Texas license, 1–2 years in sterile compounding, and a track record of leading audits and CAPAs to sustain quality and regulatory

Qualifications

  • PharmD or BS in Pharmacy from an accredited institution.
  • Active pharmacist license in good standing with the Texas State Board of Pharmacy.
  • 1–2 years of sterile compounding experience; familiarity with USP <797>, <795>, <800>, and cGMP.

Responsibilities

  • Develop, implement, and maintain QA systems in alignment with USP <795>, <797>, <800>, state board regulations and other applicable standards.
  • Monitor, document, and investigate adverse events or product complaints; report and implement CAPAs as required.
  • Conduct and oversee routine audits of sterile and non-sterile processes, facilities, and documentation.
  • Review and approve compounding records, batch release documents, and SOPs.
  • Investigate deviations and non-conformances; lead root cause analysis and corrective actions.
  • Oversee handling, storage, and qualification of raw materials and components.
  • Perform risk assessments to mitigate quality or compliance issues.
  • Coordinate and respond to quality-related inspections by state/federal agencies.
  • Maintain documentation records in compliance with requirements.
  • Support change control, validation, and qualification efforts for new processes or equipment.

Skills

Sterile compounding
Quality systems
Regulatory compliance
GMP & USP 797/800
Audit coordination

Education

PharmD or BS in Pharmacy

Job description

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
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