Deviation Writer

Deviation Writer at Harba Solutions Inc. Deviation Writer at Harba Solutions Inc. in Indianapolis, Indiana Posted in 2 days ago.

Type:

full-time

Job Description:

Responsibilities Investigate and author reports on a range of deviating conditions or nonconforming events across multiple technical departments in collaboration with subject matter experts. Gather, analyze, and interpret information to provide evidence supporting investigation conclusions and root-cause determinations. Utilize analytical tools and methodologies to identify root causes and contributing factors. Develop robust corrective and preventive actions, including the use of automation and engineering controls to strengthen processes and reduce risk. Translate complex technical information into clear, concise, and accessible written documentation. Collaborate with internal and external stakeholders to present investigation findings in a logical, comprehensive, and accurate manner. Review historical deviations and adverse events to identify trends and recommend proactive prevention strategies. Qualifications Bachelor's degree in a scientific, engineering, or technical field. At least 3 years of technical writing experience within a regulated GMP environment, ideally in pharmaceutical, biopharmaceutical, or biotechnology settings. Strong ability to work collaboratively with cross-functional teams and communicate complex information effectively to varied audiences. Demonstrated proficiency in producing clear, accurate, and high-quality technical documentation. Solid understanding of GMP manufacturing processes and regulatory expectations (preferred). Excellent organizational skills and attention to detail. Familiarity with documentation tools and electronic document management systems (EDMS) (preferred). Strong computer skills, including intermediate to advanced proficiency in Microsoft Word and Excel. Ability to manage multiple projects and meet deadlines in a dynamic environment.