Manufacturing Quality Specialist

Position: Manufacturing Quality Specialist / Deviation InvestigatorLocation: St. Louis, MO - 63134Duration: 12 Months Job Type: ContractWork Type: OnsiteShift: 03:00 PM to 11:30 PMPay Rate: $72-$72/hr

Overview: TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.

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)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 the recurrence of issuesWork 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 updates 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 & ExperienceA bachelor’s degree in science is required, preferably in a scientific discipline.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 & Knowledge, Skills, AbilitiesEquivalent combinations of education, training, and relevant work experience may be considered.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.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 processingMinimum of 7 years of experience within facilities, maintenance, and/or engineering with technical expertise in problem-solving deviations within the areas.Experience managing aged and complex investigations is required.Experience in Root Cause Analysis, LEAN/Six Sigma, or Operational Excellence toolsPrior experience with TrackWise, Root Cause Analysis, TapRooTProficiency in technical and investigative writing, with a minimum of 7 years of demonstrated experienceStrong communication skills and ability to work effectively in a collaborative environment"Positions are to support the reduction of backlog deviations. TekWissen® Group is an equal-opportunity employer supporting workforce diversity.