Packaging Operator 1

Description

The Packaging Operator I is responsible for the accurate and efficient packaging of prepared culture media products in compliance with cGMP standards. This role focuses on activities such as inspecting, labeling, boxing, palletizing, and performing line clearance. The Packaging Operator ensures that all final product is properly assembled, labeled, and staged for distribution in accordance with batch documentation and SOPs. This position plays a critical role in ensuring quality, consistency, and compliance in the final step of the manufacturing process.

• Perform packaging of finished goods using established configuration guides and packaging instructions
• Accurately label, sleeve, and box products in accordance with batch records and SOPs
• Assemble and palletize finished product for distribution, verifying product count and condition
• Perform 100% inspection of packaging components for accuracy and quality
• Conduct QC sampling per established sampling plans and document appropriately
• Maintain clear and legible documentation of all packaging activities, inspections, and batch reconciliation steps
• Operate and monitor packaging equipment and assist with startup, changeover, and shutdown procedures

• Perform packaging activities in full compliance with GMP and ISO requirements
• Participate in quality investigations and assist with reworks or label corrections as needed
• Ensure proper line clearance and cleanliness of packaging areas between batches
• Communicate quality concerns or deviations to appropriate personnel immediately
• Adhere to gowning and PPE requirements and follow cleanroom or classified area procedures

• Participate in daily team huddles and provide updates on progress and issues
• Collaborate with production, quality, and material handling teams to maintain flow of packaging operations
• Maintain a safe, clean, and organized work environment

• Accurately complete batch record entries, logbooks, and count sheets
• Use electronic systems (SAP, MES, or equivalent) to input data and confirm packaging steps

• Support continuous improvement initiatives within packaging
• Perform basic troubleshooting or escalate equipment issues
• Assist with training new team members as needed
• Perform other duties as assigned by Management

• High School Diploma or GED
• 6 months of experience in a regulated manufacturing or packaging environment

• Experience operating high-speed packaging equipment
• Knowledge of cGMP and FDA regulations
• Familiarity with SCADA/HMI interfaces

• Strong attention to detail and documentation accuracy
• Ability to follow written instructions and SOPs
• Team player with good communication skills
• Comfortable standing for long periods and lifting up to 40 lbs
• Willingness to work overtime or flexible shifts as needed
• Dependable and punctual with a strong sense of responsibility
• Ability to work efficiently in a fast-paced, repetitive environment
• Basic computer literacy and ability to complete digital forms or entries
• Self-motivated and proactive with a continuous improvement mindset
• Ability to maintain focus and accuracy during routine tasks
• Demonstrates initiative in asking questions and seeking clarification when needed
• Ability to work independently once trained, while also functioning as part of a collaborative team