Deviation Writer

INCOG Biopharma Services in Indianapolis, IN is hiring a Deviation Writer. We are seeking a highly motivated and detail-oriented individual who will help take ownership of understanding why and how deviating events occur, what immediate actions can be taken to protect our people, processes, materials, and how we can prevent re-occurrence.

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 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.

INCOG BioPharma Services is seeking an experienced and detail-oriented Specification Writer to join our Supply Chain Team. This role is crucial for translating complex technical data into clear, accurate, and accessible documentation. The Specification Writer will work closely with Supply Chain, External Vendors, Clients and other cross-functional teams to create comprehensive documentation that supports new material specifications and updates for existing specifications, ensuring that all materials meet regulatory and quality standards.

There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.

At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.

Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.

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 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.
• Experience utilizing a variety of analysis tools to support root cause identification; Ishikawa Fishbone, 5 Why, etc.
• Ability to critically think outside the box for robust corrective and preventative actions; leveraging automation and engineering controls to error-proof equipment and processes.
• Demonstrated ability to translate complex, technical processes and descriptions into simplified, understandable write ups.
• Eagerness to collaborate and partner with both internal and external stakeholders to comprehensively represent the facts of an investigation in a logical and presentable manner.
• Evaluating historical deviating conditions, adverse events, non-conformances, etc. in order to identify and prevent trends.

Candidate 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.
• Proficient in writing clear, concise, and accurate technical documentation.
• Strong understanding of GMP manufacturing processes and regulatory requirements.
• 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.

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations