Visual Inspection and Packing Operator

About the Company

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 have 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.

Job Location: Nivagen Pharmaceuticals Inc., Sacramento, CA, 3900 Duckhorn Dr, Sacramento, CA 95834.

Title of the Position:
Visual Inspection and Packing Operator

At Nivagen, the Visual Inspection and Packaging Operator plays a critical role for performing manual visual inspection of products to ensure that defined quality standards are met. The role also involves operating manual and/or automatic leak testing machines and packing equipment to prepare products for shipment. The operator must perform activities related to sterile manufacturing, as and when required, and ensure that all operations are carried out in strict compliance with company policies, standard operating procedures, applicable regulatory requirements, and current Good Manufacturing Practices (cGMP), while upholding the highest standards of product quality and safety throughout the production process.

• To perform the visual inspection of the filled containers manually i.e., vials (liquid and lyophilised), pre-filled syringes, cartridges and IV bags.
• To identify the defects i.e., Volume variation, particulate matter (such as glass pieces, any type of particles, fibres, etc.) Cosmetic defects (such as cap defects, sealing defects, label flaws, printed text matter flaws, external contamination, damage, wrong labelling, cross labelling flaws etc.) and shall ensure no defective product shall be supplied to the market.
• Reconciliation and Segregation of the good and defective containers, preparation of defect library and preparation of Knapp/qualification kits required for the qualification of automatic inspection machines.
• Assist and prepare documents (includes SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment.
• Responsible for handling, collection, transportation,and storage of the semi-finished and finished products as per product storage conditions and as per process requirements.
• Responsible for avoiding cross-contamination and mix-up errors at various stages of operations.
• Responsible for collaborating effectively with cross-functional departments to ensure timely coordination and organization of all prerequisites, supporting the smooth operation of the department and ensuring the delivery of finished products that meet market needs and business demands.
• Qualification/validation of the equipment and area in accordance with approved protocols, and preparation and readiness for the routine commercial manufacturing.
• The role requires the ability to stand, walk, and perform tasks for extended periods, lift and move products up to 35 kg, and demonstrate good hand-eye coordination and fine motor skills for inspection and packing duties.
• The role requires good eyesight, strong attention to detail, the ability to identify defects or discrepancies, and a basic understanding of visual inspection and packaging requirements.
• To perform in process, check and record details in documents in accordance with approved protocols, batch records, SOPs and regulatory guidelines.
• Collaborate closely with production staff, including operators, supervisors, and cross-functional teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required.
• Packaging of products with secondary packing materials and packing them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy.
• Perform various packaging operations such as labelling of carton/pouch, carton/pouch packaging, weighing of carton /pouch, printing and verification of batch details on carton/pouch, tertiary packaging as per packaging configuration and standards.
• Collaboration with warehouse,…