Work Schedule

Environmental Conditions

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.

Discover Impactful Work:

This role is a hands-on GMP documentation and production-support position within our sterile manufacturing operations in Greenville, NC. You will work closely with Production and Quality Assurance to review completed batch records, identify and resolve documentation issues, and help ensure records are accurate and compliant before they move forward to QA. Your attention to detail and sound judgment will directly support right-first-time documentation, efficient production flow, and cGMP compliance.

A Day in the Life:

You will support internal manufacturing customers across the sterile inspection area, spending time both at a computer and in production areas. Much of the day involves reviewing and reconciling batch documentation, partnering with Production and QA to resolve discrepancies, and helping determine when additional documentation or deviation support is needed. This is an onsite, fast-paced role for someone who can prioritize independently, manage multiple records and requests, and communicate clearly across functions.

What to expect:

• Review completed production batch records for accuracy, completeness, and adherence to current Good Manufacturing Practice (cGMP) requirements before records are submitted to Quality Assurance.
• Reconcile batch documentation and work directly with Production and QA to resolve discrepancies, missing information, and documentation errors in a timely manner.
• Serve as a knowledgeable GMP resource to manufacturing partners and help identify when deviation or additional quality documentation may be required.
• Analyze recurring batch record errors and documentation trends, helping improve record quality, process flow, efficiency, and right-first-time performance.
• Support production operations while maintaining appropriate discretion, independent judgment, and strong time-management and prioritization skills.
• Use business and manufacturing systems, including SAP, and standard computer applications to support documentation and workflow activities.
• Follow all site safety, GMP, training, and personal protective equipment (PPE) requirements.
• Work primarily Monday-Friday, generally 7:00 a.m.-3:30 p.m., with some schedule flexibility. Overtime or occasional weekend work may be required based on production needs.
• Move between buildings and production areas as needed; the role includes regular walking and other physical activity in a manufacturing environment.

Keys to Success:

Education

• High school diploma or equivalent required.

Experience

• 2+ years of experience in a GMP-regulated pharmaceutical or manufacturing environment is preferred.
• Experience reviewing, processing, reconciling, or supporting pharmaceutical batch records is strongly preferred.
• Experience partnering with Production, Manufacturing, Quality Assurance, or other cross-functional teams in a regulated environment is preferred.
• SAP experience is preferred.

Knowledge, Skills, Abilities

• Strong attention to detail with the ability to identify documentation discrepancies and follow issues through resolution.
• Working knowledge of GMP/cGMP documentation practices and the importance of data accuracy and compliance in a regulated manufacturing environment.
• Self-sufficient and dependable, with the ability to work independently after training and exercise appropriate judgment.
• Strong organization, prioritization, and time-management skills with the ability to manage multiple tasks in a fast-paced production environment.
• Clear written and verbal communication skills and the ability to collaborate effectively with Production and Quality Assurance.
• Computer proficiency and comfort learning manufacturing and business systems.

Competencies

• Attention to detail
• Accountable and dependable
• Self-motivated
• Effective communication
• Collaborative
• Sound judgment and prioritization

Physical Requirements

• Ability to perform ordinary ambulatory skills and physical coordination in an onsite manufacturing environment.
• Ability to lift, carry, and move 10-35 pounds periodically.
• Ability to stand, walk, stoop, kneel, and crouch for periods of time and travel between buildings/production areas as needed.
• Ability to use a keyboard and computer and to sit, reach, talk, and hear for extended periods.
• Ability to comply with applicable site PPE and safety requirements.