Senior Deviation/Investigation Writer

3 weeks ago

Wilson, United States eTeam Full time
Job Title: Senior Deviation/Investigation Writer (Operation)
Work Location: Wilson, NC 27893
FTE/Permanent Role (No Relocation Expenses are included)
Range: $70k to $80k per annum
Ability to work a 10 hour per day/4-day work week; 40 hours per week with overtime as required.

Need candidates who have experience writing investigation in Oral Solid Dose (OSD).

Job Summary:
  • The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Technical Operations (Manufacturing and Packaging) department.
Education and Experience:
  • Requires a Bachelors degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
Necessary Knowledge, Skills, and Abilities:
  • Demonstrate a sound understanding of cGMPs, FDA regulations, and pharmaceutical 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.
  • W orking knowledge of TrackWise or similar deviation management systems
Primary Responsibilities:
  • 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.
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