Overview
Technical Writer Jobs in Indianapolis, Indiana, USA at ZipRecruiter
Job Description Job Description
Technical Writer Deviations & Change Control
Our client, a pharmaceutical manufacturing company, is seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation. This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise, timely, and accurate technical documentation.
Key Responsibilities
Write, edit, and review high-quality technical documents including deviations, change controls, CAPAs, and other GMP-related records.
Collaborate with cross-functional teams (QA, Manufacturing, Engineering, etc.) to gather accurate and complete information.
Ensure all documentation complies with FDA, EU, and internal GMP guidelines.
Translate complex technical information into clear, concise, and well-structured documents.
Assist in audit readiness by maintaining organized, traceable documentation.
Support investigations and root cause analyses by drafting clear summaries and conclusions.
Qualifications
Bachelors degree in Life Sciences, Engineering, or a related field.
5+ years of experience in technical writing within the pharmaceutical or biotech industry.
Strong knowledge of GMP, deviation management, and change control processes.
Excellent writing, editing, and communication skills.
Proficient with Microsoft Office Suite; experience with Track Wise or other QMS platforms a plus.
Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.
Applicants must be authorized to work in the United States. Sponsorship is not available for this position.
#J-18808-Ljbffr
Title: Technical Writer
Company: ZipRecruiter
Location: Indianapolis, Indiana, USA
Category: Quality Assurance – QA/QC (Quality Engineering, Data Analyst)
