Location
Saint Louis, MO | United States
Job description
Maxonic maintains a close and long-term relationship with our direct client. In support of their needs, we are looking for a Deviation Investigator .
Job Description:
Job Title: Deviation Investigator
Location: St. Louis, MO
Job Type: Contract
Pay Rate: $65-$70/hr on W2
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.
- 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.
Qualifications:
Education
- Bachelor’s degree in science required, preferably in a scientific discipline.
- Experience
- 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).
Equivalency:
- Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, Abilities
- Proficiency in technical and/or investigative writing.
- Excellent verbal and written communication skills.
- Ability to drive functional, technical, and operational excellence.
- Ability to evaluate data and make recommendations based on data analysis.
- Ability to make recommendations based on trends and trend analysis.
- Ability to work in a fast-paced environment with the capability to prioritize effectively to meet timelines.
- Facilitation skills for groups including staff level employees.
- Excellent time management and organizational skills to meet deliverables on tight deadlines.Preferred: TrackWise, Root Cause Analysis, TapRooT
About Maxonic:
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award winning, dedicated team of recruiting professionals are specialized by technology, are great listeners, and will seek to find a position that meets the long-term career needs of our candidates. We take pride in the over 10,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Interested in Applying?
Please apply with your most current resume. Feel free to contact Sambhav Raj ([email protected] / (408) 684-6911) for more details.
Job Type: Contract
Salary: $65.00 - $70.00 per hour
Work setting:
Work Location: In person
Job tags
Salary
