FSP Packaging Preparation Technician

JOB DESCRIPTION

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Job Purpose:

Produce clinical trial materials (CTM) for domestic and international clinical trials. Responsible for performing label printing/inspection and documentation preparation activities to meet the required GMP quality standards.

This is a full-time, fully onsite role (M-F, 1st shift) at our Zebulon, NC location. This role supports our Functional Service Provider (FSP) model.

Key Responsibilities:

Must assure clinical trial materials (CTMs) are produced in accordance with packaging orders to achieve useful results. CTMs are produced in compliance with applicable regulations. Identifies problems and deviations, and makes recommendations on solutions to ensure deadlines are met. Does not perform final verification/quality critical checks unless trained to perform a specific check.

• Print and inspect clinical labels for use in clinical trials including bay set-up and line clearance.

• Prepare data entry for primary or secondary packaging documentation in accordance with GMPs and Standard Operating Procedures

• Ensure high levels of attention to detail and data accuracy to documentation

• Use systems that are critical to the delivery of labels and packaging documentation (e.g. ClinPro, PTMS, COMET, or future applicable systems), recognize when it is necessary to seek support to resolve systems issues

• Ensure routine tasks (i.e. Print head checks) are performed in accordance with their required schedule

• Executes assigned tasks and activities with high quality and attention to own and other’s safety

• Ensure that any non-standard activities that occur during label or documentation preparation are appropriately raised to team coordinator or supervisor (e.g. Deviations)

• Acts as first line resolution of quality, productivity, and safety issues.

• Verify equipment set up including quality critical settings.

• Complete and verify reconciliations of labels

• Anticipates/recognizes potential problems with equipment/materials and initiates action to address or prevent problems.

• Identifies and begins to interpret problems in processes and/or in results and communicates them to his/her supervisor

• Consults with supervisor when difficulties arise that cannot be readily resolved

• Work with trainees to complete training modules and assess training competency of specific activities.

• Participate in safety risk assessments.

• Identify and participate in delivery of continuous improvement opportunities in order to improve quality, productivity, and safety.

• Responsible for requesting labels for the on-time completion of jobs

• Participate in Quality Investigations as a technical expert in a manner subject to L2/L3/L4 scrutiny, when appropriate

• Participate in local and regulatory audits (compliance and safety).

• Write and obtain approval of observation reports

• Learning to present concise summaries of own activities in group settings

• Participate on inter-department project teams to meet company milestones and objectives

• Prepares brief oral or written summaries of results with interpretation for “projects”

• Assist in primary and secondary packaging floor operations as needed (with appropriate training)

• Development of expertise in label printing and inspection and document creation

Requirements:
• Advanced Degree with no prior experience required, or Bachelor's Degree plus 2 years of experience in packaging/labeling engineering, preferably in pharmaceutical, medical device, or regulated industries
• Preferred Fields of Study: Packaging Engineering, Mechanical Engineering, Chemical Engineering, or related technical field
• Strong knowledge of packaging materials, equipment, and label printing technologies
• Expertise in GMP requirements and regulatory compliance standards
• Experience with packaging validation and documentation (IQ/OQ/PQ)

Competencies:

Sufficient education, experience and knowledge of the following:

• GMPs (current Good Manufacturing Practice) and other applicable regulatory requirements

• Understanding of the development process and demonstrated experience in the clinical supplies area is required. Knowledge of GMP label creation and packaging operations to support clinical trials.

• Ability to work independently with minimal supervision. Ability to prioritize tasks and work in a flexible manner with some supervisory input.

• Should be detailed oriented.

• Basic PC operation (Email, Windows, word processing, database, spreadsheet applications)

• Ability to write documents

• Good interpersonal skills.

• Ability to adhere to written instructions (i.e. follow the rules and guidelines of the department).

• Developing sound judgment, decision-making skills and strong organizational skills. Beginning to influence others.

• Must exhibit strong communication, negotiation, and interpersonal skills.

• Ability to function on a high-performance team.

• Ability to listen and follow verbal instructions.

• Ability to perform trouble shooting and problem solving with supervision. Ability to follow-up and evaluate problems appropriately.

• Ability to double-check the work of others for accuracy.

• Ability to build team spirit.

• Participate and support implementation of change.