FTE Senior Deviation / Investigation Writer (Operations)
Company: Katalyst Healthcares & Life Sciences
Posted on: March 17, 2023
- 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.
- 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
- 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
- Update, author and review standard operating procedures and
other controlled documents as a result of process improvements and
- Initiate Change Controls as required for Manufacturing and
- Collaborate with SMEs from other departments to ensure a cross
functional evaluation is completed and ensure alignment of GxP
- 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
- Requires a bachelor's degree, preferably in a scientific
discipline, with a minimum of 3-5 years of experience in a
pharmaceutical or related industry.
- Demonstrate a sound understanding of cGMP's, FDA regulations,
and pharmaceutical manufacturing/packaging processes.
- Minimum of 3 years manufacturing or technical experience in a
regulated GxP environment, oral solid dosage
- Experience in troubleshooting, investigation, and
root-cause/analytical/problem-solving capabilities in a GxP
- 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 Trackwise or similar deviation management
- Perform job functions in various positions that may require
sitting, stooping, balancing, kneeling, crouching, twisting, and/or
- 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
- Ability to work a 10 hour per day/4-day work week; 40 hours per
week with overtime as required.
Keywords: Katalyst Healthcares & Life Sciences, Wilson , FTE Senior Deviation / Investigation Writer (Operations), Advertising , Wilson, North Carolina
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