FTE Senior Deviation​/Investigation Writer; Operations

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.

• Requires a Bachelor’s degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a related industry.

• 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.

• 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.