Deviation Writer

Deviation Writer at Lead Candidate Deviation Writer at Lead Candidate in Fishers, Indiana Posted in 4 days ago.

Type:

full-time

Job Description:

WHO? 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. WHAT? 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. YOU! 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. 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 Don't meet all the requirements? Don't sweat! We're always looking for an excuse to discuss your next opportunity. You might just surprise yourself... Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.