GMP Technical Writer — QA & CAPA Specialist

Gregory Pharmaceutical Holdings, Inc.; Bristol (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Gregory Pharmaceutical Holdings, Inc. in Bristol, Tennessee seeks a Quality Assurance professional to create, revise, and maintain forms, SOPs, batch records, and material specs, enhancing GMP compliance.

You will author and collaborate on NOEs/Investigations and identify CAPAs with cross-functional teams. Requires a science/engineering degree and 5+ years in GMP pharma manufacturing/packaging, plus strong writing, data analysis, and FDA regulatory knowledge.

Qualifications

• Bachelor’s degree in a science/engineering field and 5+ years of manufacturing or packaging pharmaceutical experience in a GMP environment.
• Strong technical writing skills and ability to analyze complex data for regulatory compliance.
• Experience with cGMPs and FDA requirements (21 CFR 210 and 211).

Responsibilities

• Conduct cross functional investigations, deviations, and product complaints and determine CAPAs.
• Review procedures and batch records for alignment with company policies and government regulations.
• Collaborate with authors of procedures to improve usability and compliance.
• Develop testing protocols and analyze data to support corrective actions.

Skills

Teamwork

Analytical thinking

Technical writing

Problem solving

Communication

Education

Bachelor's degree in science/engineering

Tools

MS Office

Datalogging systems

Job description

Gregory Pharmaceutical Holdings, Inc. in Bristol, Tennessee seeks a Quality Assurance professional to create, revise, and maintain forms, SOPs, batch records, and material specs, enhancing GMP compliance.

You will author and collaborate on NOEs/Investigations and identify CAPAs with cross-functional teams. Requires a science/engineering degree and 5+ years in GMP pharma manufacturing/packaging, plus strong writing, data analysis, and FDA regulatory knowledge.