-
Deviation Investigator
5 days ago
Intelliswift Software St Louis, United StatesJob Description · Title: Deviation Investigator · Duration: 6 Months on W2 · Location: St. Louis, MO · Details: · Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · • Coach and drive root ...
-
Deviation Investigator
2 weeks ago
Indotronix Avani Group St Louis, United StatesJob Title: Deviation Investigator · Location: St. Louis, MO · Duration: 6+ Months · Pay rate: $112/hour on W2 · 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, Co ...
-
Deviation Investigator
5 days ago
KellyMitchell Group St Louis, United StatesJob Summary: · Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · Dutie ...
-
Deviation Investigator
1 week ago
Katalyst HealthCares & Life Sciences St. Louis, United StatesResponsibilities: 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 ...
-
Deviation Investigator
1 week ago
KellyMitchell Group St Louis, United StatesJob Summary: · Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · Dut ...
-
Deviation Investigator
1 week ago
Procom St Louis, United StatesDeviation 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 it ...
-
Deviation Investigator
1 week ago
Katalyst Healthcares and Life Sciences St Louis, United StatesResponsibilities: ssume 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 ...
-
Deviation Investigator
2 weeks ago
KellyMitchell Group St Louis, United StatesJob Summary: · Our client is seeking a Deviation Investigator to join their team in St. Louis, Missouri The selected candidate will assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · Duti ...
-
Business Professional
1 week ago
LanceSoft St Louis, United StatesJob Description: · Monday to Friday office hours · How will you make an impact? · Assume site level responsibility for all major investigations including items originating from Production, Quality Control, Facilities, etc. · •Coach and drive root cause analysis (RCA) · •Facil ...
-
Clinical Research Physician
1 week ago
Medix™ St Louis, United StatesWe are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Neurologist to break into the Clinical Research field. Apply today or send your CV to: · Must Have: · Candidate must be a current Neurologist · Summary: · The Principa ...
-
Clinical Research Physician
1 week ago
Medix™ St. Louis, United StatesWe are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Dermatologist to break into the Clinical Research field. Apply today or send your CV to: · Must Have: · Candidate must be a current Dermatologist · Summary: · The Prin ...
-
Clinical Research Physician
1 week ago
Medix St Louis, United StatesWe are hiring for a Research Physician/Principal Investigator in St Louis. Great opportunity for a well rounded Neurologist to break into the Clinical Research field. Apply today or send your CV to: Lorena.lanouecarrizo@ · Must Have: · Candidate must be a current Neurologist · Su ...
-
Quality Manager
1 week ago
Elemental Enzymes Inc St Louis, United StatesJob Description · Job Description Salary: · Quality Manager · The Quality Manager will lead the Quality Assurance and Quality Management Systems functions within the Manufacturing division and will provide oversight to ensure compliance with applicable quality objectives and reg ...
-
Quality Assurance Manager
1 week ago
a Medical Devices company located in St. Louis, MO area St Louis, United StatesSr. QC Manager · RESPONSIBILITIES · Ensuring the timely and accurate testing of materials and company products while maintaining and ensuring all quality and compliance requirements are satisfied. · Providing oversight and guidance on day-to-day activities of chemists and bioche ...
-
clinical research specialist
1 week ago
Washington University in St. Louis Saint Louis, MO, United StatesScheduled Hours · 40 · Position Summary · The responsibility of the Clinical Research Specialist is to direct and coordinate all aspects of multi-center clinical research trials, which include tactical management, administration and leadership of project teams to ensure the proje ...
-
RPM ReSearch Saint Louis, United StatesJob Description · Job DescriptionJob Description · Position Title · Senior Scientist/ Principal Investigator - Bioanalysis DMPK Biotransformation · We are looking for an accomplished scientist to join our growing drug discovery DMPK and Small Molecule Bioanalysis team. Our site h ...
-
Construction Project Manager
5 days ago
PuroClean Emergency Restoration Services of Caseyville St Louis, United StatesJob Description · Job Description · Project Manager · A fast growing, leading edge restoration company, PuroClean, has built our business by exceeding clients expectations every day and on every on project. PuroClean is looking for an energetic and highly motivated individual ...
-
Quality Engineer
1 week ago
Stereotaxis St Louis, United StatesShift TypeJob TitleQuality EngineerEducationBachelor's DegreeLocationStereotaxis - St. Louis, MO 63101 US (Primary)Career LevelEntry LevelCategoryRegulatory and ComplianceDate Needed ByJob TypeFull-timeTravelJob DescriptionCompany Description:Stereotaxis is the global leader in i ...
-
Quality Engineer
2 days ago
Stereotaxis St Louis, United StatesShift Type · Job Title · Quality Engineer · Education · Bachelor's Degree · Location · Stereotaxis - St. Louis, MO 63101 US (Primary) · Career Level · Entry Level · Category · Regulatory and Compliance · Date Needed By · Job Type · Full-time · Travel · Job Descript ...
-
Quality Engineer
27 minutes ago
Stereotaxis St Louis, United StatesShift Type · Job Title · Quality Engineer · Education · Bachelor's Degree · Location · Stereotaxis - St. Louis, MO 63101 US (Primary) · Career Level · Entry Level · Category · Regulatory and Compliance · Date Needed By · Job Type · Full-time · Travel · Job Descript ...
Deviation Investigator - St Louis, United States - Intelliswift Software Inc
Description
Job Description
Title: Deviation Investigator
Duration: 6 Months on W2
Location: St. Louis, MO
Details:
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.
Education:
Bachelors 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, Tap RooT
