Lead Ops Training Coordinator (8hr night shift, Sunday-Thursday)

ThermoFisher Scientific; Greenville (NC); On-site; USD 70,000 - 95,000; Full time

Job summary

Thermo Fisher Scientific in Greenville, NC is seeking a Lead Operations Training Coordinator to develop and maintain comprehensive training programs for manual visual inspection in a GMP manufacturing setting. You will ensure staff acquire the knowledge and skills to uphold quality and regulatory standards.

The role involves designing content, maintaining documentation, coordinating audits, and collaborating across departments to drive continuous learning and operational excellence.

Qualifications

• Minimum 3 years of GMP manufacturing experience, preferably in pharma/clinical operations and manual visual inspection.
• Experience in training or supervisory roles is preferred.
• Formal training qualification or certification is a plus.
• Equivalent combinations of education and experience may be considered.
• Strong knowledge of cGMP and good documentation practices.
• Experience developing and delivering training programs and materials.
• Proficiency with LMS and training documentation systems.

Responsibilities

• Train and mentor new hires on packaging and labeling inspection.
• Certify operators on assigned job duties and conduct annual sitewide certification.
• Coordinate and deliver onsite training sessions; schedule classes.
• Monitor training room readiness and maintain training records.
• Evaluate inspection methods and support process improvements.
• Review inspection data and assist with customer complaint meetings.
• Write and revise training SOPs and ensure regulatory documentation compliance.
• Support supervisors with daily training activities and cross-functional communication.

Skills

GMP knowledge

Training program development

Cross-functional collaboration

LMS experience

PowerPoint & Excel

Regulatory audits support

Documentation practices

Education

High school diploma/GED

Bachelor's degree in Education/Training or relevant

Tools

LMS

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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. Shift hours are 6pm - 2am, Sunday-Thursday)

Location/Division Specific Information:

Greenville, NC

How Will You Make an Impact?

We are seeking a Lead Operations Training Coordinator at Thermo Fisher Scientific, where you will have a key role in developing and maintaining comprehensive training programs for our manual visual inspection operations. You will ensure employees are equipped with the knowledge and skills needed to maintain our high standards of quality and compliance in pharmaceutical manufacturing. Working in a GMP environment, you will coordinate comprehensive training initiatives, develop engaging content, and support a culture of continuous learning and excellence.

Your contributions will enhance the organization as you design and implement training programs, maintain documentation systems, and ensure regulatory compliance. You will collaborate with cross-functional teams to identify training needs, create effective learning solutions, and track program effectiveness. This role contributes directly to our mission of enabling our customers to make the world healthier, cleaner, and safer.

Key Responsibilities:

Training & Certification

• Train and mentor new hires on packaging and labeling inspection
• Certify operators on assigned job duties
• Conduct annual sitewide inspection certification training
• Coordinate and deliver onsite training sessions
• Schedule and coordinate training classes
• Monitor training room daily for readiness
• Maintain training records and report completion data
• Evaluate inspection rooms for proper techniques and manipulation usage

Inspection & Quality Support

• Review inspection vials for AQL findings
• Create and maintain defect libraries
• Develop inspection methods for new products
• Evaluate processes and recommend improvements
• Provide inspection expertise for customer complaint meetings

Training Tools & Equipment

• Create and maintain inspection test kits
• Perform annual preventative maintenance on test kits
• Repair and enhance inspection training test kits
• Calibrate and maintain inspection hoods

Documentation & Compliance

• Write and revise inspection and training SOPs and protocols
• Review and approve training room documentation
• Enter training documents into Learning Administration systems
• Ensure documentation compliance with site and regulatory requirements

Operational Support

• Support supervisors with daily operational and training activities
• Facilitate cross-functional communication on training and quality initiatives
• Maintain training room organization and compliance

REQUIREMENTS

Education

• High school diploma/GED is minimally required.
• Bachelor's degree in a relevant subject area is preferred.
• Preferred Fields of Study: Education, Training, or relevant discipline.

Experience

• Required: Minimum of 3 years of experience in GMP manufacturing environment, preferably in pharmaceutical or clinical operations, preferably in manual visual inspection
• Preferred: At least 1 year in a training or supervisory capacity. Other roles and responsibilities in a training or educational capacity will be considered.
• Preferred: Formal training qualification or certification.
• Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities:

• Strong knowledge of cGMP regulations and good documentation practices
• Experience developing and delivering training programs and materials
• Proficiency in Learning Management Systems (LMS) and training documentation systems
• Advanced skills in Microsoft Office Suite, particularly PowerPoint and Excel
• Experience with e-learning platforms and digital training tools
• Experience supporting regulatory audits and inspections
• Demonstrated ability to collaborate effectively across departments

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.