QA Architect – Sterile Compounding & Compliance

Remedy; Missouri City (TX); On-site; USD 130,000 - 135,000; Full time

Benefits offered by this job

Base pay $130k-$135k

Medical, dental & vision

Flexible time off

Stock options

Job summary

Thirty Madison, now part of Remedy, seeks a QA/Compliance Pharmacist to own the quality system for our 503A compounding pharmacy, ensuring facility readiness for inspections and accreditation.

You will author, maintain, and train staff on SOPs across operations, including environmental monitoring, deviation/CAPA, and change control, serving as SME during audits.

Texas-licensed pharmacist with BCSP and 5+ years in sterile compounding is required, with strong regulatory experience and SOP ownership.

Qualifications

• Active Texas pharmacist license.
• BCSCP, in good standing.
• 5+ years in sterile compounding with quality-system ownership.
• Experience designing or rebuilding an EM program with sampling rationale.
• Regulatory compliance experience beyond USP 797, including licensure and DEA.

Responsibilities

• Write the quality system from scratch: SOPs, training, and competency.
• Design the environmental monitoring program with risk-based sampling.
• Build and run personnel qualification programs and trend data.
• Approve facility SOPs and third-party reports; coordinate investigations.
• Own the 503A framework and licensure processes including DEA.

Skills

SOP authorship

Deviation/CAPA

Regulatory defense

Communication skills

Education

Texas pharmacist license

Job description

Thirty Madison, now part of Remedy, seeks a QA/Compliance Pharmacist to own the quality system for our 503A compounding pharmacy, ensuring facility readiness for inspections and accreditation.

You will author, maintain, and train staff on SOPs across operations, including environmental monitoring, deviation/CAPA, and change control, serving as SME during audits.

Texas-licensed pharmacist with BCSP and 5+ years in sterile compounding is required, with strong regulatory experience and SOP ownership.