Technical Writer
Listed on 2026-10-15
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Production QC/QA, Quality Control - QC Analysts/Managers
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.
Requirements:
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.
Work Environment: Fully onsite; aseptic or sterile gowning required as needed.
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