Currax Pharmaceuticals LLC · 1 day ago
Quality Specialist
Brentwood, TN
Full-time
Onsite
Mid Level
3+ years expCurrax Pharmaceuticals LLC is a specialty pharmaceutical company focused on providing increased access to life-changing medications for patients and healthcare providers. The Quality Specialist will support the development and maintenance of the Currax Pharmaceutical Quality System, managing critical quality system elements and ensuring compliance with policies and regulations.
BiotechnologyPharmaceutical
Responsibilities
Support the day-to-day quality systems for all Currax commercial and clinical products
Support the administration of Currax’s eQMS system
Provide Quality support of US based clinical trials, production, distribution, and drug safety/pharmacovigilance activities
Actively collaborate with Supply Chain, Regulatory Affairs, Tech Ops, and management to ensure compliance with Currax policies, procedures, and industry regulations
Engage in activities to continuously assess and improve processes including the development of SOPs and other policies or procedures
Support the evaluation of internal and supplier quality records such as complaints, deviations, CAPAs, change controls, production records, and investigations within the Currax eQMS and external web software/applications
Support the development and management of the Currax training program
Provide Quality support for approved suppliers and contract manufacturing organizations (CMO), including oversight of supplier/CMO records, maintaining the approved supplier list, assisting in maintaining Quality Agreements, and supporting internal and external audits
Participate in internal and external meetings and site visits to ensure cGxP compliance
Support routine Quality functions and meetings such as the monthly quality meetings, internal audits, management reviews, and annual product reports
Support Batch Record Review and Drug Product disposition activities
Other duties appropriate for this role as required or directed by QA Management
Qualification
Required
3-5+ years of progressive experience in a GMP environment required
Minimum of 1 year of Quality Assurance experience in support of GMP clinical/commercial production
Previous exposure to quality records such as deviations, CAPAs, investigations, and product complaints
Excellent organizational and communication (oral and written) skills
Excellent problem-solving and troubleshooting skills
Ability to interpret applicable standards and objectively make decisions with support of management
Ability to quickly learn, navigate, and work within new software and web applications
Proficiency in MS Office Suite, specifically Outlook, Word, Excel, and PowerPoint
Ability to work in a fast-paced, timeline driven corporate office setting
High level of flexibility and willingness to learn
Preferred
Bachelor's degree in a scientific discipline
Experience in electronic quality management systems
Experience with the application of GMPs and GDPs within the pharmaceutical industry
Experience working with external partners in a Quality Assurance capacity
Familiarity with the manufacturing and packaging process of solid oral dosage and liquid drug products
Benefits
Health
Retirement
Paid leaves
Wellness programs
Medical
Dental
Vision coverage
401(k) plan with company match
Paid time off and holidays
Other benefits to support your physical, financial, and social well-being
Company
Currax Pharmaceuticals LLC
Currax delivers innovative, life-changing medicines to patients living with chronic, progressive diseases.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
G
George Hampton
President & CEO
Recent News
MarketScreener
2025-11-04
2025-10-30
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