Senior Packaging Labeling Technician

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

• Able to lift 40 lbs. without assistance
• Adherence to all Good Manufacturing Practices (GMP) Safety Standards
• Cold Room/Freezers -22degreesF/-6degrees C
• Laboratory Setting
• Office
• Somewhat degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Standing for full shift
• Warehouse

Key Duties & Responsibilities

• Act as a senior/lead technician within the commercial packaging and labeling group by providing guidance, training support, and operational oversight to junior team members.
• Oversee batch record runs and verify completion accuracy to ensure compliance with Good Documentation Practices (GDP), ALCOA principles, SOPs, and client requirements.
• Review Master Production Records (MPRs) and supporting documentation for accuracy, completeness, and compliance prior to execution and product release activities.
• Accurately complete and review batch records, ensuring documentation integrity and regulatory compliance.
• Accept/reject product to ensure materials meet acceptability and quality standards.
• Accurately count and prepare product to ensure accurate inventory before and after the completion of each job order.
• Support operational readiness activities for commercial and clinical packaging campaigns.
• Respond to emails and inquiries related to commercial packaging and labeling operations.
• Have a knowledge of and support /or lead deviation investigations, CAPAs, change controls, and non-conformance documentation using TrackWise.
• Troubleshoot packaging and labeling equipment issues and escalate concerns appropriately to minimize operational downtime.
• Support basic equipment setup, operation, adjustment, and troubleshooting activities related to commercial packaging and labeling processes.
• Timely complete training on operating requirements, procedures, and compliance standards.
• Interact effectively with multiple functional areas including Management, Quality Assurance, Client Services, Shipping, Engineering, Validation, and IT.
• Follow all applicable SOPs, GMP, GDP, and company policies.

Basic Minimum Qualifications

• Communicate effectively verbally and in written form.
• Strong organizational skills and the ability to prioritize work in a fast-paced GMP environment.
• Knowledge of pharmaceutical packaging, labeling, batch record documentation, and GDP requirements.
• Have a working knowledge of TrackWise or comparable quality management systems.
• Work with methods to handle, process, and store specimens.
• Knowledge of Universal Precautions, general laboratory practices, and quality assurance/control.
• Ability to multi-task across Operations, Project Management, QA, and Facilities Management activities.
• Effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.

Work Conditions / Physical Requirements

• Must have ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, and marked changes in temperature.
• Must use personal protective equipment and adhere to safety protocols.
• Must be able to lift and carry up to 50 lbs and push up to 70 lbs.
• Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
• Must have dexterity and attention to detail to manually label vials (RFT) in a cold environment that meet quality standards as laid out in batch records.
• Must be able to use a computer up to 6 hours per day.

What We Offer

• Competitive Pay
• Performance Related Bonus where eligible
• Annual merit performance-based increase
• Excellent Benefits
• Medical benefits
• Paid Time Off/Annual Leave
• Employee Referral Bonus
• Career Advancement Opportunities