Nivagen Pharmaceuticals is hiring: Visual Inspection and Packing Operator in Sac

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'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.

Job Location:

Nivagen Pharmaceuticals Inc., Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834.

About the Job:

Title of the Position: Visual Inspection and Packing Operator

At Nivagen, the Visual Inspection and Packaging Operator plays a critical role in ensuring product quality and compliance. This position is responsible for conducting manual visual inspections to verify that products meet established quality standards. Additionally, the operator will oversee the operation of leak testing machines and packaging equipment to ensure products are properly prepared for shipment. All tasks must be performed in strict adherence to company protocols and regulatory requirements, maintaining the highest standards of product quality and safety throughout the production process.

Responsibilities:

• To perform the visual inspection of the filled containers i.e., vials (liquid and lyophilized), pre-filled syringes, cartridges and IV bags.
• To identify the defects i.e., fill volume inconsistencies, glass pieces, metal, colored particles, fibers, cap defects, sealing defects, label flaws, printed text matter flaws, batch coding flaws, wrong labelling, cross labelling flaws etc. and shall ensure no defective product shall be supplied to the market.
• Segregation of the defects and preparation of defective library and preparation of Knapp kits required for the qualification of automatic inspection machines.
• Preparation of the documents (including SOPs, batch records), protocols required for operation and maintenance of the VI, leak testing and packing equipment.
• Responsible for collection, transportation, and storage of the semi-finished products as per product storage conditions.
• Shall take utmost care to avoid the cross-contamination and mix-up errors.
• Shall be responsible for the storage of the semi-finished and finished products
• Collaborate 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.
• To perform in process, check and controls in accordance with approved protocols, batch records, SOPs and regulatory guidelines.
• Collaborate closely with production staff, including operators, supervisors, and quality control teams, to ensure product quality and timely delivery, while actively participating in team meetings and training sessions as required.
• Prepare products for secondary packing using the correct materials and pack them according to company specifications. Ensure packaging is sealed, labelled correctly, and checked for completeness and accuracy.
• Collaboration with warehouse, production, in-process quality teams for timely support and product deliverables to meet OTIF.
• Adhere to safety guidelines, promptly report hazards or accidents, and ensure the work area remains clean and organized.
• Involved in daily operations, including cleaning, maintaining logs, and overseeing routine packing activities to ensure efficiency and compliance
• Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans
• Managing market complaints, conducting investigations, implementing corrective actions, and preventing future occurrences.
• Inventory management for the consumables required for the day-to-day packing activities.
• Any other tasks as directed by the supervisor.

Education:

• High school diploma or equivalent required; technical certification or degree in a related field is a plus.

Experience:

• 1-3 years of experience in pharmaceutical manufacturing, visual inspection, or packaging

Knowledge and Skills:

• cGMP, FDA regulations, and SOPs related to sterile and non-sterile pharmaceutical production.
• Strong attention to detail and ability to detect visual defects.
• Proficiency in operating inspection and packaging equipment.
• Ability to follow written instructions and complete documentation accurately.
• Good communication and teamwork skills.

Requirements:

• Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents)
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles' radius)
• Able to successfully complete a drug and background check
• 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.
• Must comply with cleanroom protocols, gowning, and PPE requirements.
• The role requires strong attention to detail, the ability to identify defects or discrepancies, a basic understanding of quality control and packaging requirements, the capacity to work efficiently in a fast-paced environment while maintaining high standards, and good manual dexterity for handling delicate products.

Benefits:

• Pay range $20.0 - $25.0 per hour (Based on Experience)
• 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

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.