Job Information
Cogent Infotech FTE Senior Deviation/Investigation Writer (Operations) in United States
Job Summary
Perform investigation activities and writing deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
Write concise and accurate investigation reports.
Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
Initiate Change Controls as required for Manufacturing and Packaging operations.
Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
Responsible for compliance with Controlled substance documentation and accountability procedures while maintaining high alert to diversion and theft possibilities.
Perform other related assignments and duties as required and assigned. Education and Experience
Requires a Bachelor’s degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a related industry.
Necessary Knowledge, Skills, and Abilities
Demonstrate a sound understanding of cGMP’s, FDA regulations manufacturing/packaging processes.
Minimum of 3 years manufacturing or technical experience in a regulated GxP environment, oral solid dosage manufacturing/packaging preferred.
Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear and accurate.
Demonstrated ability to work independently and as part of a collaborative, cross-functional team. Working knowledge of Track Wise or similar deviation management system. Physical and Environmental
Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
While sitting for an extended period of time on a routine basis, incumbent may use the following equipment: Personal computer, telephone/ other voice communication devices, copier, fax, scanners, or other specialized equipment used in an office setting.
Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required. Additional Information
