Quality Specialist jobs in United States
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Southend Pharmacy · 1 day ago

Quality Specialist

Southend Pharmacy is a modern 503A compounding pharmacy focused on longevity-aligned therapeutics. The Quality Specialist will ensure compliance with regulatory standards and maintain high-quality standards for compounded medications while supporting operational excellence.

Retail
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Responsibilities

Refine and expand the batch release program and serve as a primary lead for visual inspection processes to verify product quality prior to distribution
Oversee the investigation of quality-related incidents, such as deviations or complaints; perform Root Cause Analysis (RCA) and implement Corrective and Preventive Actions (CAPA)
Develop and implement QA programs to ensure consistent compliance with USP , , and standards, FDA 503A regulations, and state pharmacy laws
Help maintain accurate records of compounding activities and writing/revising SOPs from scratch
Conduct regular internal audits of compounding processes and facility operations to ensure all documentation is audit-ready for the State Board of Pharmacy or FDA
Train pharmacy staff on aseptic techniques and SOPs; monitor adherence to cleanroom protocols and proper execution of compounding procedures
Monitor, calibrate, and validate compounding equipment and cleanroom environments to ensure adherence to sterile compounding standards
Train pharmacy staff on quality control procedures, aseptic techniques, and gowning protocols to ensure consistent adherence to best practices

Qualification

Sterile compoundingQuality management systemsRegulatory complianceRoot Cause Analysis (RCA)CorrectivePreventive Actions (CAPA)Aseptic techniquesAnalytical skillsStaff trainingInternal auditsAttention to detailWritten communicationVerbal communicationDocumentation

Required

High school diploma
Must hold an active and unencumbered license (Pharmacist, Pharmacy Technician, or Technician Trainee) with the Texas State Board of Pharmacy (TSBP)
Minimum of 1-2 years of experience in sterile compounding (503A or 503B) with a strong understanding of USP , , and or cGMP standards
Expert attention to detail and analytical skills for data trending
Proficiency in aseptic techniques and quality management systems
Excellent written and verbal communication skills for documentation and staff training

Preferred

Bachelor's degree in pharmacy, chemistry, biology, or a related field
1+ year in a dedicated Quality Assurance or compliance-related role
Relevant certifications (e.g., Certified Quality Auditor or advanced sterile compounding certification)

Benefits

Comprehensive benefits package including medical, dental, paid time off.
401(k) retirement savings plan.
Eligible for quarterly bonus based on performance.
Ample opportunities for professional development and career growth.

Company

Southend Pharmacy

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Southend Pharmacy offers healthcare providers a partnership that extends beyond the script, delivering innovative care solutions and seamless support.

Funding

Current Stage
Growth Stage
Company data provided by crunchbase