QA Specialist– Visual Inspection and Packaging

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. For over a decade, we’ve remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees’ well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

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.

Nivagen Pharmaceuticals, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

At Nivagen as an In Process QA Specialist you will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise, ensuring that all production activities comply with Good Manufacturing Practices (GMP) and regulatory requirements.

• Provide real-time QA oversight during visual inspection, secondary and tertiary packaging, and final dispatch operations for sterile injectable products.
• Perform real-time review and verification of batch manufacturing and packaging records during execution.
• Perform and document the AQL visual inspections in accordance with approved procedures and sampling requirements.
• Perform artwork verification and review/approval of labelling and packaging components, including specimen labels and printing details.
• Verify issuance, accountability, reconciliation, and proper use of labels, cartons and other packaging materials required for batch packaging as per packaging record.
• Perform packaging material reconciliation and reject verification.
• Verify line clearance and area readiness prior to applicable visual inspection and packaging activities.
• Identify, document, and support investigation (as applicable), documentation, labeling, packaging, and material discrepancies.
• Perform QA verification of rejected units and packaging components, as applicable.
• Coordinate and verify the collection/removal of retention samples, stability samples, finished product samples, and other required samples.
• Provide QA oversight during final dispatch activities, including verification of applicable product, labeling, packaging, shipment, and dispatch documentation prior to release for shipment.
• Verify that applicable batch, shipment, and dispatch records are complete, accurate, and appropriately reconciled prior to final dispatch.
• Ensure product and associated materials are appropriately identified, accounted for, and released in accordance with approved procedures.
• Review executed documentation for completeness, accuracy, traceability, and compliance with GDP and cGMP requirements.
• Work closely with Manufacturing, Packaging, QC, Warehouse, Supply Chain, and other cross-functional teams to ensure timely resolution of…