In Process QA Associate

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Requirements

• Perform routine on-the-floor QA oversight within manufacturing areas
• Conduct line clearances, in-process checks, and verification activities during manufacturing and packaging operations
• Review and approve GMP documentation including batch production records, logbooks, sampling records, and associated manufacturing documentation
• Support deviation investigations by gathering information, participating in root cause analysis, and assisting with CAPA development and effectiveness checks
• Support the authoring, review, and approval of QA Manufacturing procedures, controlled documents, and Master Batch Records to ensure compliance with cGMP, regulatory requirements, and internal quality standards
• Participate in GMP area walkthroughs and support inspection readiness activities
• Support internal audits, regulatory inspections, and customer audits by preparing documentation and providing operational support
• Collaborate cross-functionally with Manufacturing, Engineering, Validation, and Supply Chain teams to resolve quality issues and drive continuous improvement
• Assist with product disposition activities and quality review processes under supervision
• Promote a culture of quality, compliance, and operational excellence within the organization

Benefits

• Pay range $70,000 - $80,000 per Year
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
• Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan