GMP Technical Writer - Documentation & Compliance

Catalent, Inc.; Greenville (NC); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Competitive PTO

Benefits from day one

Tuition reimbursement

Site activities and events

ERGs and inclusion programs

Green initiatives and community work

Career development opportunities

WellHub wellness program

Perkspot discounts

Job summary

Catalent Pharma Solutions in Greenville, NC is hiring a Technical Writer to collect, organize, format and author manufacturing documents. This 100% onsite role interacts with SMEs, Operations and QA to ensure accurate, compliant documentation for master batch records and protocols.

Work with cross-functional teams to update systems, support audits and maintain quality standards. The position emphasizes clear communication, GMP compliance and efficient document control in a fast-paced

Qualifications

• Requires STEM degree with 1+ year experience; OR
• Assoc degree in STEM with 2+ years experience; OR
• HS diploma with 3+ years industry experience
• Proficient with GMP documentation requirements and quality systems
• Proficient with MS Office and database tools
• Strong written and verbal communication and project management skills
• Ability to lift up to 40 lbs and push/pull up to 100 lbs
• Comfort with onsite, collaborative work in a manufacturing environment

Responsibilities

• Collaborate with SMEs to gather information for new or updated documents
• Review documents with Operations to ensure accuracy and harmonized formatting
• Maintain accurate inputs in the documentation database
• Contribute inputs to Manufacturing Resource Planning for events
• Close out help desk tickets for document corrections
• Provide information during client and FDA audits
• Participate in cross-functional project teams
• Support electronic document management system implementation
• Coordinate document approvals across the organization
• Adapt to changing priorities across packaging and manufacturing

Skills

Quality systems

GMP

MS Office

Presentation

Project management

Communication

Physical ability

Education

Bachelor's degree in STEM

Associate degree in STEM

High school diploma + experience

Tools

MS Word

Excel

Adobe Acrobat Pro

Database software

Job description

Catalent Pharma Solutions in Greenville, NC is hiring a Technical Writer to collect, organize, format and author manufacturing documents. This 100% onsite role interacts with SMEs, Operations and QA to ensure accurate, compliant documentation for master batch records and protocols.

Work with cross-functional teams to update systems, support audits and maintain quality standards. The position emphasizes clear communication, GMP compliance and efficient document control in a fast-paced