Jobs at Nivagen Pharmaceuticals, Inc.

Provide customer support for product orders, pricing, shipping and account management; process and track orders; coordinate cross-functionally to resolve issues; maintain records; support onboarding, quality/compliance escalation, warehouse picking/packing, and continuous improvement initiatives within FDA-regulated operations.

Perform aseptic, cGMP-compliant sterile drug manufacturing in ISO cleanrooms: operate and maintain formulation, filtration, filling, autoclave and sterilization equipment; perform visual/AQL inspection, documentation, environmental monitoring, gowning, and cleaning; assist investigations, batch records, and quality activities; follow SOPs and regulatory guidelines.

Perform routine and specialized cleaning/sanitization of Grade A-D cleanrooms per SOPs and cGMP. Prepare disinfectants, maintain cleaning logs and Master Cleaning Schedule, don proper gowning/PPE, report anomalies, support audits, and collaborate with QA, Facilities, and Manufacturing to maintain aseptic conditions and regulatory compliance.

As a Microbiologist, you will ensure pharmaceutical products meet quality standards by conducting tests, developing methods, and maintaining compliance with regulations.

The In Process QA Associate is responsible for ensuring pharmaceutical products meet quality standards through monitoring, testing, and documentation during manufacturing, ensuring compliance with GMP and regulations.