Onsite GMP Technical Writer for SOPs, PBRs & Logbooks

Indotronix Avani Group; Plainville (MA); On-site; USD 65,000 - 95,000; Full time

Job summary

Indotronix Avani Group is seeking a documentation specialist to develop, revise, and format SOPs, PBRs, logbooks, job aids, and technical reports for cGMP manufacturing. You will collaborate with SMEs to verify and document technical information and manage controlled document workflows with QA involvement.

The role requires strong technical writing, proofreading, and GMP compliance understanding; onsite work with potential aseptic/gowning procedures as needed.

Qualifications

• High School Diploma with 5+ years of related experience; Associate’s Degree with 3–4 years; or Bachelor’s Degree with 1–2 years.
• Strong technical writing, communication, interviewing, and proofreading skills.
• Proficiency in computers and related software applications.
• Understanding of GMP compliance, manufacturing documentation, and safety procedures.
• Ability to gather technical details from SMEs and develop clear, structured documents.

Responsibilities

• Develop, revise, and format SOPs, batch production records (PBRs), logbooks, job aids, and technical reports for cGMP manufacturing.
• Collaborate with SMEs and technical specialists to gather, verify, and document technical information.
• Manage controlled document workflows, issuance, revisions, and archiving in coordination with Quality Assurance.
• Proofread documentation for accuracy, completeness, quality standards, and GMP compliance.
• Maintain SOP manuals and manufacturing logbooks.
• Train junior associates on documentation standards and support continuous improvement initiatives.

Skills

Technical writing

Communication

Interviewing

Proofreading

Education

Bachelor's degree

Associate’s degree

High school diploma

Tools

Computers and software

Job description

Indotronix Avani Group is seeking a documentation specialist to develop, revise, and format SOPs, PBRs, logbooks, job aids, and technical reports for cGMP manufacturing. You will collaborate with SMEs to verify and document technical information and manage controlled document workflows with QA involvement.

The role requires strong technical writing, proofreading, and GMP compliance understanding; onsite work with potential aseptic/gowning procedures as needed.