Description:Works closely with cross-functional teams, including product design, quality assurance, production management, various engineering functions, and laboratory staff to lead and conduct investigations into non-conformities and other quality deviations to identify root causes and effective corrective actions.
Collaborate with those same cross functional teams to implement such corrective actions.The investigation process may involve data mining, conducting statistical analysis, and applying statistical tools in order to identify trends, evaluate measurement systems, process capabilities and stability, in addition to validating the corrective actions and establishing proper controls.
Must be able to write and document investigations in a well-organized structure presenting the investigation steps, root causes, and corrective actions clearly and concisely.Skills:technical writing, capa, validation, quality engineering, fda, investigation, root cause analysis, investigation and analysis, deviationTop Skills Details:technical writing,capa,validation,quality engineering,fda,investigation,root cause analysisAdditional Skills & Qualifications:Bachelor of Science in Engineering or Science (Biology, Microbiology, Chemistry, Biochemistry) is required 4-5 years related experience in an FDA Regulated Industry (Pharma or Medical Device) is required.Open to any regulated industry experience to include aerospace.Experience Level:Entry Level About Actalent:Actalent connects passion with purpose.
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Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.