Visual Inspection and Packing Operator

Visual Inspection and Packing Operator

Nivagen Pharmaceuticals LLC, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834.

Title of the Position: Visual Inspection and Packaging 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.

Responsibilities:

• 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, 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 visual /packing activities to ensure efficiency and compliance
• Tracking defect trends, maintaining control over defect storage, conducting periodic reviews, and implementing control and mitigation plans
• Assist and 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.
• Handling of Autoclave, Isolator and Filling machine as and when required.
• Must be aware of clean room gowning.
• Any other duties 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 be willing to move to the 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 $18 - $25 per hour
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental and vision coverage
• Paid time off plan
• 401 (k) 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.

Nivagen Pharmaceuticals, Inc.