Team Leader Operations Batch Record Review

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Location/Division Specific Information

Greenville, NC

RELOCATION ASSISTANCE IS NOT PROVIDED

• Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
• Must be able to pass a comprehensive background check, which includes a drug screen.

Discover Impactful Work:

In this role, you will support and coordinate Production batch record review activities to ensure accuracy, completeness, and compliance prior to submission to Quality Assurance. You will partner closely with Operations and cross-functional teams to resolve documentation issues, support timely product release, and contribute to a culture of quality and continuous improvement.

A Day in the Life:

• Coordinate daily batch record review activities and prioritize team workload
• Serve as a point of contact for routine questions, issue resolution, and escalations
• Perform detailed batch record review to ensure compliance with procedures and cGMP standards
• Identify and resolve documentation errors in collaboration with QA and Production teams
• Track key performance metrics and escalate risks to quality or delivery
• Support onboarding and training of team members
• Maintain knowledge of systems, procedures, and regulatory requirements
• Contribute to continuous improvement initiatives and process enhancements
• Promote safe work practices and compliance with all safety requirements

Keys to Success:

Education

• Bachelor’s degree in a scientific or related field OR equivalent experience (5+ years)

Experience

• 2–4 years of experience in pharmaceutical or regulated manufacturing
• Experience with batch record review, documentation, or quality operations preferred

Knowledge, Skills, Abilities

• Strong attention to detail and commitment to accuracy
• Working knowledge of cGMP and regulated environments
• Ability to follow procedures and ensure compliant documentation
• Strong communication and cross-functional collaboration skills
• Problem-solving skills with ability to escalate complex issues
• Ability to manage multiple priorities in a fast-paced environment
• Strong organizational and time management skills
• Ability to maintain confidentiality and exercise sound judgment

Competencies

• Customer-focused mindset
• Accountability and ownership
• Effective communication
• Team collaboration
• Continuous improvement orientation

Additional Information

• Supervisory responsibility for a team of 2–6 employees
• Reports to Manager, Operations Support
• Ability to work in an aseptic or controlled environment
• Ability to stand, walk, and perform physical tasks as required (10–35 lbs occasionally)