QE Investigator

Act as a Corporate and plant resource to standardize investigations through process evaluation, template development and training.  Provide quality engineering consulting (to include investigations, CAPA and training) to support Corporate and plant activities.  Evaluate process/procedure changes as necessary and assure changes are implemented in associated plant procedures.  Track, trend, and act on CAPA program requirements in a systematic and effective way to assure timely closure.  Promote consistency in investigation practices across Corporate and plants.  Review and evaluate sensitive, confidential information and develop recommendations for use by plant Quality and Corporate Quality management.  Actively participate in Six Sigma projects.   ROLE RESPONSIBILITIES Perform and document investigations regarding plant issues and critical defect audit failures. This may include investigation of Production, Incoming Quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation. Conduct personnel interviews and system reviews.  Act as an unbiased investigator with questions surrounding the specific issue. Supervise the Quality Investigator I's and II's by reviewing and approving low and medium level investigations. Evaluate corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur. Perform follow-up activities to coordinate the completion of corrective and/or preventive actions. Perform effectiveness checks for investigations. Design studies as needed to gather critical data for investigations and/or corrective actions. Track, on a daily basis, the progress of all investigations as they pertain to Exception Reports/Quality Assurance Reports.  Report progress in the weekly  department meetings and Product Flow Optimization ( PFO) meetings. Remain current in regulatory expectations and industry practices regarding investigations and CAPA. QUALIFICATIONS Requires Bachelor's degree in scientific field or equivalent pharmaceutical experience. Requires a minimum of 2 - 5 years of CAPA, investigations, or manufacturing quality assurance experience, or a minimum of 6 - 8years manufacturing/technical experience in a pharmaceutical or regulated GMP environment. Strong oral, written, communication, presentation and interpersonal skills.  Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel.  Superior technical writing and problem solving skills required.  In-depth knowledge of exception documentation procedures and requirements. Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail into the SmartCAPA software. Must have project management or project development experience within pharmaceutical, medical device or related healthcare industry with demonstrated successful results. Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox) PREFERRED QUALIFICATIONS Experience using data analysis computer tools and statistical analysis is preferred.   Experience working in a cross-functional, matrix environment. ASQ Certified Quality Engineer and Six Sigma Green Belt preferred. 4719896
Salary Range: NA
Minimum Qualification
5 - 7 years

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