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 with minimal supervision. Supports development and assists with implementation of improvements in productivity, compliance and safety. Participates on teams producing CTM.

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

Key Responsibilities:

Must assure clinical trial materials (CTMs) are produced in accordance with clinical protocol to achieve useful results. CTMs are produced in compliance with applicable federal regulations. Identifies problems and raises to supervision.

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)

Specific Activities:

• Prepare and review appropriate clinical supplies documentation.

• Assist in set-up and running of packaging jobs in accordance with the required quality and safety standards.

• Exhibit good verbal and written communication skills. Document information relative to preparation, packaging, and shipping of clinical supplies in accordance with cGMPs and departmental SOP’s.

• Able to identify problems to supervision. Assist in conducting investigations, assessment of options and implementation of solutions in order to maintain a fully compliant operation within CSC.

• Performs other duties as assigned.

Competencies

Sufficient education, experience and knowledge of the following:

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

• 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

• Ability to lift or move 40 pounds throughout the facility.

• 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.