GMP Technical Writer: Audit-Ready Documentation & SOPs

Grow in Greenville, NC; Greenville (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Competitive Paid Time Off and holidays

Medical, dental, and vision benefits

Tuition reimbursement program

Site-based activities and diversity/in

Onsite fitness center

Job summary

Catalent's Greenville, NC site is seeking a Technical Writer to develop and update essential manufacturing documentation, ensuring accuracy and regulatory compliance. You will support audits, coordinate approvals, and maintain documentation systems for manufacturing and packaging activities.

Shift is Monday–Friday, 8am–5pm, onsite in Greenville, NC, with opportunities to contribute across cross-functional projects and drive improvements in electronic document systems.

Qualifications

• Bachelor’s degree in a STEM-related field or an equivalent combination of education and experience.
• At least 1 year of technical writing experience preferred.
• Familiarity with GMP documentation requirements and quality systems.

Responsibilities

• Collaborate with SMEs to gather information for Master Batch Records, protocols, and related change control documents.
• Review documents for accuracy, executability, and formatting consistency with input from Operations.
• Maintain the documentation database and ensure inputs meet company standards.

Skills

Technical writing

Attention to detail

Cross-functional collaboration

Documentation standards

Education

Bachelor's degree in STEM

Associate degree in STEM with 2+ years

High school diploma with 3+ years of experience

Tools

Microsoft Word

Excel

Adobe Acrobat Pro

Database management software

Job description

Catalent's Greenville, NC site is seeking a Technical Writer to develop and update essential manufacturing documentation, ensuring accuracy and regulatory compliance. You will support audits, coordinate approvals, and maintain documentation systems for manufacturing and packaging activities.

Shift is Monday–Friday, 8am–5pm, onsite in Greenville, NC, with opportunities to contribute across cross-functional projects and drive improvements in electronic document systems.