Link Pharmacy · 21 hours ago
Quality Assurance (QA) Specialist – Sterile Compounding
Highland Village, TX
Full-time
Onsite
Entry, Mid Level
$36/hr - $40/hr
1+ years expLink Pharmacy is a 503A pharmacy focused on sterile operations. They are seeking a Quality Assurance (QA) Specialist to support the Quality Management System, ensuring compliance with USP and FDA standards through document control, environmental monitoring, and inspection readiness.
Pharmaceuticals
Responsibilities
Maintain and control SOPs, logs, and records related to sterile compounding
Ensure USP procedures are current and accurately implemented
Perform routine cleanroom and buffer area compliance walkthroughs
Support internal audits and inspection readiness activities
Assist during FDA and state board inspections
Document and track deviations, incidents, and nonconformances
Support root cause analysis and CAPA implementation
Track and trend quality findings for sterile operations
Support media fill documentation and aseptic process validations
Maintain personnel qualification and requalification records
Qualification
Required
Associate's or Bachelor's degree in Life Sciences, Quality, Pharmacy, or related field (or equivalent experience)
1–3 years experience in sterile compounding, quality, or regulated healthcare environment
Working knowledge of USP
Strong documentation and organizational skills
Attention to detail and compliance accuracy
Strong written and verbal communication
Ability to recognize and escalate sterility risks
Time management and prioritization skills
Proficiency with Excel and quality tracking tools
Preferred
Experience in a 503A sterile compounding pharmacy
Cleanroom or ISO-classified environment experience
Familiarity with FDA or state board inspections
Pharmacy Technician Certification (CPhT)
Company
Link Pharmacy
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase