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Quality Assurance Analyst - Compounding Laboratory

American Statistical Association - ASA

Quality Assurance (QA) AnalystAt The Pharmacy Hub, we collaborate with pharmaceutical brands, manufacturers, health brands, telemedicine providers, and healthcare companies to deliver essential products directly to patients. Our expertise allows us to seamlessly distribute pharmaceuticals, medical devices, and other healthcare products to consumers, ensuring greater accessibility and convenience.Job SummaryThe Quality Assurance (QA) Analyst supports and maintains the Quality Management System (QMS) for the compounding laboratory. The role provides independent quality oversight of compounding operations, documentation, materials, equipment, facilities, and personnel practices to ensure compliance with approved SOPs, applicable quality standards, and regulatory requirements. The analyst works cross-functionally with Production, Quality Control, Pharmacy, Inventory, R&D, and Management to identify compliance gaps, investigate quality events, implement CAPAs, and promote continuous improvement.Key ResponsibilitiesMonitor compounding operations for compliance with approved SOPs, quality standards, and applicable requirements, including USP ; and USP ; as relevant.Perform routine QA inspections and internal audits of production, storage, packaging, labeling, and support areas; document observations and track corrective actions.Review controlled documentation and quality records for completeness, accuracy, traceability, and Good Documentation Practices (GDP).Document and investigate deviations, nonconformances, process failures, rework, rejected batches, and other quality events; support root-cause analysis and CAPA development, tracking, and effectiveness checks.Support change control for formulas, equipment, materials, suppliers, processes, facilities, systems, and controlled documents.Provide floor-level quality oversight of gowning, hygiene, cleaning, line clearance, material handling, labeling, equipment status, and production documentation.Verify appropriate receipt, identification, labeling, storage, status, and traceability of raw materials, including hazardous materials and materials requiring special controls.Support QA training, retraining, competency activities, product-quality complaint investigations, and audit readiness.Track quality metrics and trends, including deviations, CAPAs, complaints, rework, QC rejections, documentation errors, audit observations, and training compliance.QualificationsBachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Quality Assurance, or a related scientific field preferred.Previous experience in pharmaceutical compounding, pharmacy operations, pharmaceutical manufacturing, or a regulated laboratory environment preferred.Knowledge of Quality Assurance principles and QMS; familiarity with USP, USP, GDP, CAPA, deviations, investigations, and change control preferred.Strong attention to detail, documentation, organization, analytical thinking, and problem-solving skills.Ability to identify compliance gaps, communicate findings professionally, and manage multiple quality activities simultaneously.Experience with non-sterile compounding, audit preparation, internal inspections, root-cause analysis, and electronic quality/document systems preferred.Proficiency with Microsoft Office and/or Google Workspace. Bilingual English/Spanish is a plus.What We OfferCompetitive salary.Opportunities for growth in a rapidly expanding telepharmacy practice.Collaborative and innovative work environment focused on patient safety and compliance.Work Schedule8:00AM to 5:00PMThis is a full-time position, working 44 hours per week, Monday through Friday. This is a 100% onsite role; remote or hybrid work is not available. Pay Range $55,000-$60,000 USDBenefits:401(k) with up to 4% matchingMedical, dental, vision and life insurancePaid time off that grows with your tenureCore ValuesThe Pharmacy Hub is dedicated to breaking barriers in healthcare by championing access, intervention and affordability.Customer-first mindset - we develop strong partnerships with telehealth platforms and healthcare companies to enhance access and understand their specific needsInnovation for intervention in care - we develop advanced compounding solutions and products to better support patient health outcomesContinuous improvement - we continuously improve our processes and offerings through intelligent, honest and transparent practices to deliver cost-effective solutions that truly benefit our clients and their patients.You will play a pivotal role in maintaining these values and contributing to the company's mission of redefining healthcare delivery through superior pharmacy services.At The Pharmacy Hub, we don't just offer jobs-we offer opportunities for career growth and development. We take pride in our fast-paced, team-driven culture and are committed to supporting our employees in achieving success. If you're ready to join a company that values hard work, dedication, and teamwork, apply today! We look forward to welcoming you to The Pharmacy Hub and working together to deliver top-tier pharmacy fulfillment solutions.The Pharmacy Hub is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Applicants requiring a reasonable accommodation to participate in the hiring process are encouraged to indicate this in their application. The Pharmacy Hub participates in E-Verify. A post-offer background check is required for all positions. Additional pre-employment screenings may apply depending on the role. American Statistical Association - ASA

Vacancy posted 1 day ago
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