Quality Specialist

Quality Specialist

Brentwood, TN | Full Time

Actual compensation will depend on a candidate's education, experience, skills and geographic location. Currax offers best in class benefits programs that includes health, retirement, paid leaves, and wellness programs.

About Currax

Currax Pharmaceuticals LLC is a specialty pharmaceutical company focused on providing increased access to life-changing medications for patients and healthcare providers. We seek to improve patient health and quality of life through the acquisition and commercialization of medications, including Contrave, the number one branded oral anti-obesity medication in the U.S.

At Currax, we take pride in our mission to serve patients, and we value authenticity and collaboration in our workplace. As we experience an exciting period of accelerated growth, our organization is rich with opportunities to gain hands-on experience and fulfill career aspirations while making a direct impact on the lives of patients we serve.

About the Role

The Quality Specialist reporting into the Quality Manager will be responsible for supporting the development and maintenance of the Currax Pharmaceutical Quality System. This role will support the quality system elements pertaining to all commercial and clinical trial products. Additionally, this role will manage and oversee critical quality system elements pertaining to document management, supplier management, product dispositions, deviations, change control, CAPA, and support Quality Management Review.

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

Required Qualification & Skills

• 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 Qualification & Skills

• 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

Currax Core Values

• Integrity
• Passion
• Accountability
• Commitment
• Teamwork

Currax is committed to the health and well-being of our employees and families and offers a comprehensive benefits package. Available benefits include medical, dental, and vision coverage, 401(k) plan with company match, paid time off and holidays, and other benefits to support your physical, financial, and social well-being.

Currax Pharmaceuticals LLC does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact Human Resources at human.resources@curraxpharma.com Read our full EEO statement at http://www.curraxpharma.com/careers/eeo-statement/