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Quality Technician – 503A Sterile Compounding jobs in United States
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Link Pharmacy · 1 day ago

Quality Technician – 503A Sterile Compounding

Link Pharmacy is a 503A pharmacy focused on sterile operations. The Quality Technician – Sterile Compounding supports daily quality and compliance activities, ensuring ongoing sterility assurance and regulatory compliance through documentation review and routine compliance checks.
Pharmaceuticals

Responsibilities

Maintain quality records, logs, and forms related to sterile compounding
Perform routine reviews of compounding, cleaning, and monitoring logs
Identify documentation errors and escalate discrepancies
Support daily and scheduled cleanroom compliance walkthroughs
Verify adherence to USP procedures and work instructions
Escalate observed deviations or potential sterility risks
Assist with documentation of deviations, incidents, and near-misses
Collect and organize supporting records for investigations
Track assigned corrective actions under QA supervision
Assist with collection of viable and non-viable environmental monitoring samples
Label, document, and track EM samples and results
Notify QA leadership of out-of-specification or action-level results
Maintain EM logs and assist with trending activities
Track USP training and competency records
Verify completion of gowning and aseptic technique qualifications
Support onboarding documentation for sterile compounding personnel
Assist with media fill and personnel qualification documentation
Assist with receipt and documentation of sterile supplies and components
Verify lot numbers, expiration dates, and supporting documentation
Support quarantine and release processes under QA direction
Support internal audits and mock inspections
Organize quality records for FDA and state board inspections
Provide documentation support during inspections

Qualification

Sterile compounding experienceEnvironmental monitoringDocumentation skillsPharmacy Technician CertificationCleanroom experienceAttention to detailOrganizational skillsCommunication skills

Required

High school diploma or equivalent (Associate's degree preferred)
1–2 years experience in sterile compounding, healthcare, or regulated environment
Ability to follow written procedures and maintain accurate documentation
Computer and data entry skills

Preferred

Experience in a 503A sterile compounding pharmacy
Cleanroom or ISO-classified environment experience
Exposure to USP
Pharmacy Technician Certification (CPhT)

Company

Link Pharmacy

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Funding

Current Stage
Growth Stage
Company data provided by crunchbase