GMP Technical Writer – Onsite Documentation & Compliance

Catalent; Greenville (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Paid time off

8 holidays

Tuition reimbursement

Onsite wellness

Employee resource groups

Job summary

Catalent in Greenville, NC seeks a Technical Writer to collect, organize, format, and author manufacturing documents, including Master Batch Records and protocols. This onsite role collaborates with SMEs, reviews content for accuracy, and maintains the documentation database to support audits.

Ideal candidate has a STEM degree with experience in GMP environments, strong MS Office and Adobe skills, and solid communication and project management abilities.

Qualifications

• Requires degree in STEM with at least 1 year of relevant experience; or an associate degree with 2 years; or a high school diploma with 3 years in industry.
• Familiar with GMP documentation requirements.
• Proficient with Word, Excel, Adobe Professional and database software.
• Effective presentation and communication skills; strong project/resource management.

Responsibilities

• Collaborate with SME to gather information for new/updated documents such as Master Batch Records and protocols.
• Review documents for accuracy, executable content, and formatting consistency.
• Maintain documentation database accuracy and ensure inputs meet company standards.
• Support Manufacturing planning inputs for events and close out help desk tickets.
• Assist during client and FDA audits and participate in cross-functional teams.
• Contribute to electronic document system implementation and cross-organizational approvals.
• Adapt to shifting priorities to support packaging and manufacturing activities.

Skills

Presentation skills

Communication

Project management

Attention to detail

Education

Bachelor’s degree in STEM

Associate degree in STEM

High school diploma

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Database management software

Job description

Catalent in Greenville, NC seeks a Technical Writer to collect, organize, format, and author manufacturing documents, including Master Batch Records and protocols. This onsite role collaborates with SMEs, reviews content for accuracy, and maintains the documentation database to support audits.

Ideal candidate has a STEM degree with experience in GMP environments, strong MS Office and Adobe skills, and solid communication and project management abilities.