Senior QC Technical Writer - Audit-Ready GMP Mastery

Confidential; North Carolina; On-site; USD 95,000 - 150,000; Full time

Job summary

Confidential in North Carolina seeks a QC Senior Technical Writer to author, review, and manage QC documents in a regulated cGMP environment. You will ensure lab reports, SOPs, and investigations comply with FDA regulations, GDP, and audit readiness, while supporting multiple programs.

Responsibilities include authoring SOPs, data verification, CAPA support, and cross-functional collaboration with QA/QC and analytical teams.

Qualifications

• Bachelor’s degree required with extensive cGMP experience.
• Experience writing SOPs, reports, and investigation documentation.
• Deep understanding of FDA 21 CFR Parts 210/211 and data integrity.

Responsibilities

• Author, edit, and maintain QC SOPs, test methods, specs, and protocols.
• Interpret QC data from tests (HPLC, ELISA, Microbiology) to generate compliant reports.
• Write and support investigations, CAPAs, deviations, and OOS documentation.
• Manage document lifecycle and version control using eQMS.
• Collaborate with QA/QC and analytical scientists to standardize docs.
• Ensure all docs meet cGMP, ICH, and regulatory standards.
• Support client visits, audits, and regulatory inspections.
• Ensure areas are cGMP compliant and audit-ready.
• Able to support 24/7 manufacturing.

Skills

Quality Compliance

Regulatory Knowledge

Leadership

Documentation Excellence

Data Interpretation

Audits

Education

Bachelor’s Degree in Chemistry, Biochemistry, Microbiology or related field with 10+ years of experience

Master of Science in related discipline with 5+ years of experience

Ph.D. in Science with 3+ years of experience

Job description

Confidential in North Carolina seeks a QC Senior Technical Writer to author, review, and manage QC documents in a regulated cGMP environment. You will ensure lab reports, SOPs, and investigations comply with FDA regulations, GDP, and audit readiness, while supporting multiple programs.

Responsibilities include authoring SOPs, data verification, CAPA support, and cross-functional collaboration with QA/QC and analytical teams.