QA Deviation Investigator

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 • 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 "Requirements: - Bachelor's degree in an engineering or maintenance discipline, with a minimum of 5-7 years of experience in problem-solving tools such as RCA, TapRooT, Fishbone/6M, Kepner-Tregoe, Comparative Analysis, etc. - Minimum of 7 years of experience in a regulated environment, preferably in biologics/pharmaceuticals, with expertise in either upstream or downstream processing - Minimum of 7 years of experience within facilities, maintenance and/or engineering with technical expertise in problem solving deviations within the areas - Experience in Root Cause Analysis, LEAN/six sigma, or Operational Excellence tools - Proficiency in technical and investigative writing, with a minimum of 7 years of demonstrated experience - Strong communication skills and ability to work effectively in a collaborative environment" Comments for Suppliers: Positions are to support reduction of backlog deviations. Experience managing aged and complex investigations required 100% on site position. Monday to Friday office hours