Category: Manufacturing & Production

Employment Type: Contract

Reference: BH-372687

Deviations Investigator
Saint Louis- MO ON SITE
6 month W2 contract (with potential to extend or transition to perm)
Pay rate: $95-112/hour - Depending on Education and Experience

Summary:
M-F Business Hours

Responsibilities:
Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc.

• 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.
• Provide insights based on technical experience and astute judgment as called upon during investigations and daily interpretation of data and results.
• Perform technical writing of challenging investigations.
• Drive client communications and responses to closure through concurrences.
• Lead the team in the absence of management.
• Assign the daily deviation workload in the absence of management

• Bachelor's degree in science required, preferably in a scientific discipline.
  • Equivalent combinations of education, training, and relevant work experience may be considered.
• Minimum of 5-7 years of experience in direct utilization of problem-solving tools (RCA tools including 5-Whys, TapRooT, Fishbone/6M, Kepnor-Tregoe, Comparative Analysis, etc.) with demonstrated success.
• At least 7 years of experience working in a regulated environment, preferably in biologics/pharmaceuticals.
• Preferred experience in either upstream or downstream processing.
• Experience in Root Cause Analysis and/or LEAN/six sigma experience or Operation Excellence tools.
• Minimum of 7 years of technical and/or investigative writing with demonstrated proficiency in implementing effective CAPAs based on investigation results.
• Demonstrated ability to perform intermediate to advanced levels of MS Office functions (Word, PowerPoint, Excel).
• Proficiency in technical and/or investigative writing.
• Ability to make recommendations based on trends and trend analysis.
• Excellent time management and organizational skills to meet deliverables on tight deadlines.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs