Senior Technical Writer, Manufacturing Sciences & PPQ

SGS Consulting; Charlotte (NC); On-site; USD 85,000 - 110,000; Full time

Job summary

SGS Consulting in the RTP area seeks a Technical Writer to support Parenteral Facility manufacturing campaigns. You will apply expertise in fill/finish, visual inspection, and packaging to document investigations and project implementations.

This role emphasizes leading documentation efforts, writing PPQ Protocols and Reports, data verification, and MSM creation, with strong collaboration across cross-functional teams and adherence to cGMP regulations.

Qualifications

• Life Science background with at least 5 years experience preferred.
• Experience writing PPQ Protocols and PPQ Reports.
• Knowledge of data verification for reports and MSM creation.
• Strong written communication skills and ability to lead investigations.

Responsibilities

• Provide written documentation expertise for clinical and commercial manufacturing campaigns.
• Lead investigations and project implementation for Manufacturing Sciences.
• Write PPQ Protocols and PPQ Reports and verify source data.
• Create Master Sample Matrix (MSM) for on-floor activities.

Skills

Communication

Project Management

Technical Writing

Team Leadership

Analytical Skills

cGMP Knowledge

Education

Life Science degree

Job description

SGS Consulting in the RTP area seeks a Technical Writer to support Parenteral Facility manufacturing campaigns. You will apply expertise in fill/finish, visual inspection, and packaging to document investigations and project implementations.

This role emphasizes leading documentation efforts, writing PPQ Protocols and Reports, data verification, and MSM creation, with strong collaboration across cross-functional teams and adherence to cGMP regulations.