- Coach and drive root cause analysis (RCA)
- Facilitate cross functional teams to evaluate causal factors.
- Provide written documented investigations per the site rubric in an appropriate and timely manner.
- Ensure adequate CAPAs are put in place to reduce or eliminate recurrence of issues
- Work without direct guidance and minimal oversight to get results, meet timelines, and improve processes.
- Effectively communicate with peers and colleagues regarding the status of investigations and offer recommendations based on investigation outcomes.
- Provide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and results.
- Perform work with little to no oversight.
- Perform technical writing of challenging investigations.
- Provide oversight for technically challenging investigations.
- Provide client communications and responses.
- Drive client communications and responses to closure through concurrences.
- Provide mentorship to deviation management team members.
- Lead the team in the absence of management.
- Assign the daily deviation workload in the absence of management.
- Attending Tier III for deviation updated when needed.
- Takes ownership of Tier I problem solving and daily accountability.
- Acts proactively to ensure streamlined process operations and promote team collaboration.
- Promotes a respectful and collaborative work environment.
- Bachelor's degree in an engineering, scientific, or maintenance discipline
- 7 years of experience in a regulated environment,
- preferably in biologics/pharmaceuticals, with expertise in either upstream or downstream processing
- 7 years of experience within facilities, maintenance and/or engineering with technical expertise in problem solving deviations within the areas
- 5-7 years of experience in problem-solving tools such as RCA, TapRooT, Fishbone/6M, Kepner-Tregoe, Comparative Analysis, etc.
- Experience in Root Cause Analysis, LEAN/six sigma, or Operational Excellence tools
- Experience with tools TrackWise, Root Cause Analysis, TapRooT
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Deviation Investigator - St Louis, United States - Procom
Description
Deviation Investigator - On behalf of our client, Procom Services is searching for a Deviation Investigator to join their team for a 6-month contract opportunity in St. Louis, MO.Job Summary:
You'll assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.
Job Details:
6-month contract + possible extensions/conversion to FTE
Start Date:
ASAP
