Deviation Writer

INCOG BioPharma Services • Fishers, IN

1d • Onsite

About The Position

INCOG BioPharma Services is seeking an experienced and detail-oriented Deviation Writer to join their Manufacturing Engineering team. This role is crucial for translating a variety of complex technical events into clear, accurate, and robust investigations. The Deviation Writer will work closely with the 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 Deviation Writer will exemplify excellent interpersonal skills and be capable of developing productive customer-centric working relationships with internal and external customers and have a role with high visibility to all departments. The Deviation Writer will have strong familiarity with industry standard electronic Quality Management System(s) and Microsoft Office suite products. They will thrive working autonomously utilizing strong self-management and organization skills but also be able to interact, collaborate, and lead within a team environment. The Deviation Writer will value the processes owned by internal customers and subject matter experts and will possess a demonstrated ability to support and influence positive outcomes in the application of that knowledge to wider processes. At INCOG BioPharma, they have built a world-class CDMO for parenteral injectable drugs. Their culture and priorities are focused on building long-term value for customers, committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. They are looking for individuals who crave the challenge of creating systems from scratch and believe they have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market.

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.

Nice To Haves

• 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, particularly moderate to expert level experience with Microsoft Word and Microsoft Excel.

Responsibilities

• 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 fact gather, analyze information, interpret data, utilize expertise from Subject Matter Experts, etc. in an effort to provide supportive evidence to the investigation and root cause.
• Utilize a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
• Critically think outside the box for 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.
• Collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
• Evaluate historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees