Deviation Writer
INCOG BioPharma, Fishers, IN, United States
Job Overview
INCOG BioPharma Services is seeking an experienced and detail‑oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer works closely with Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross‑functional teams to create comprehensive investigations that leverage facts and data to support robust root‑cause conclusions, effective corrective actions, and systematic all‑encompassing preventative actions. The role requires excellent interpersonal skills, ability to develop productive customer‑centric relationships with internal and external customers, and high visibility across departments.
The Deviation Writer should have strong familiarity with industry standard electronic Quality Management System(s) and the Microsoft Office suite, work autonomously with strong self‑management and organization skills, and collaborate within a team environment.
Essential Job Functions
Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
Self‑motivated to gather facts, analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supporting evidence for investigations and root causes.
Experience utilizing analysis tools such as Ishikawa Fishbone and 5 Why to support root‑cause identification.
Critically think outside the box to develop robust corrective and preventative actions, leveraging automation and engineering controls to error‑proof equipment and processes.
Translate complex, technical processes and descriptions into simplified, understandable write‑ups.
Eagerness to collaborate and partner with internal and external stakeholders to present investigation facts logically and presentably.
Evaluate historical deviating conditions, adverse events, nonconformances, etc., to identify and prevent trends.
Special Job Requirements
Bachelor’s degree in a scientific, engineering, or technical discipline.
Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
Additional Preferences
Proficient in writing clear, concise, and accurate technical documentation.
Strong understanding of GMP manufacturing processes and regulatory requirements.
Excellent organizational skills with high attention to detail.
Ability to collaborate effectively with cross‑functional teams and communicate complex information to diverse audiences.
Familiarity with documentation tools and electronic document management systems (EDMS).
Exceptional computer skills; expert level experience with Microsoft Word and Microsoft Excel.
Equal Opportunity Employer Statement
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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INCOG BioPharma Services is seeking an experienced and detail‑oriented Deviation Writer to join our Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer works closely with Manufacturing, Production Engineering, Manufacturing Sciences and Technology, Supply Chain, Quality, and other cross‑functional teams to create comprehensive investigations that leverage facts and data to support robust root‑cause conclusions, effective corrective actions, and systematic all‑encompassing preventative actions. The role requires excellent interpersonal skills, ability to develop productive customer‑centric relationships with internal and external customers, and high visibility across departments.
The Deviation Writer should have strong familiarity with industry standard electronic Quality Management System(s) and the Microsoft Office suite, work autonomously with strong self‑management and organization skills, and collaborate within a team environment.
Essential Job Functions
Understand, investigate, and author a variety of deviating conditions or nonconforming events across multiple technical departments, in alignment with Subject Matter Experts.
Self‑motivated to gather facts, analyze information, interpret data, and utilize expertise from Subject Matter Experts to provide supporting evidence for investigations and root causes.
Experience utilizing analysis tools such as Ishikawa Fishbone and 5 Why to support root‑cause identification.
Critically think outside the box to develop robust corrective and preventative actions, leveraging automation and engineering controls to error‑proof equipment and processes.
Translate complex, technical processes and descriptions into simplified, understandable write‑ups.
Eagerness to collaborate and partner with internal and external stakeholders to present investigation facts logically and presentably.
Evaluate historical deviating conditions, adverse events, nonconformances, etc., to identify and prevent trends.
Special Job Requirements
Bachelor’s degree in a scientific, engineering, or technical discipline.
Minimum of 3 years of experience in technical writing within a regulated GMP environment, preferably in the pharmaceutical, biopharmaceutical, or biotechnology industries.
Additional Preferences
Proficient in writing clear, concise, and accurate technical documentation.
Strong understanding of GMP manufacturing processes and regulatory requirements.
Excellent organizational skills with high attention to detail.
Ability to collaborate effectively with cross‑functional teams and communicate complex information to diverse audiences.
Familiarity with documentation tools and electronic document management systems (EDMS).
Exceptional computer skills; expert level experience with Microsoft Word and Microsoft Excel.
Equal Opportunity Employer Statement
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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