Quality Investigator

Job Description:Quality Engineer leads efforts in site quality assurance programs and improvement activities. He/she is responsible for identifying and implementing programs to ensure regulatory compliance with cGMPs, ICHQ7, IPEC guidelines, ISO regulations as well as FDA requirements. The Senior Quality Engineer is accountable for direct support of several systems, including CAPA, cGMP, Complaint Investigation and Response, ISO System, Stability, SPC (supporting the microelectronic, pharmaceutical and reagent product lines as necessary) and Validation.Quality Engineer acts as the key contact working directly with customers to investigate and resolve complaints and inquiries to ensure expectations are met as well as hosting and managing customer audits, certification/surveillance audits as well as the internal audit program. He/she works collaboratively with other departments in both a leadership and participative manner to integrate the necessary systems.Work Schedule: 1st Shift (Monday - Friday)MAJOR JOB DUTIES AND RESPONSIBILITIES:Leads programs and improvement activities focused on ensuring ongoing effectiveness of the quality management system in accordance with the ISO and GMP requirementsLeads customer complaint investigations requiring direct interaction with customers as well as raw material suppliersManages and leads audit activities within the site including GMP, regulatory, customer and internal audits; recommends and implements activities to close gaps identified in audits to ensure compliance with applicable requirementsPerforms internal audits at other *** sites and may participate in supplier audits as requiredResponsible for maintaining Corrective and Preventive Action program activities within specific scope of responsibility to identify and implement effective corrective actionsEnsures facility cGMP compliance is maintained and identifies/implements improvement programs as requiredProvides GMP and GDP training to site personnelLeads efforts to drive improvement efforts in global metrics with specific focus on complaints and complaint response time as well as CAPAsWorks with and provides input to Management of Change processPerforms statistical evaluations for processes and trending and leads validation activity associated with new products or changes to existing processes and productsWorks collaboratively with supplier quality personnel to identify and resolve quality related issues impacting site performance as well as customer complaintPartners collaboratively with external customers, operations leadership, and interacts with all levels of plant operations, R&D, procurement, commercial and quality teamsWorks with all departments to investigate and resolve process and product quality issuesPerforms other duties as assigned with or without accommodationSkills/Experience:KNOWLEDGE, SKILLS AND ABILITIES:Excellent writing and presentation skillsDemonstrated ability to accomplish goals through othersDemonstrated familiarity with chemical nomenclature and Quality Control testing and methodsAbility to merge divergent resources into an effective and efficient cross-functional teamHighly detail oriented with demonstrated strong analytical and problem solving skillsAbility to navigate in a matrixed environment and work collaboratively in a team environmentExcellent organization and project management skillsAbility to interface effectively with people at all levels of the organization, from executive to production lineWORKING CONDITIONS:The work environment is a manufacturing facility, and the appropriate PPE will be required in designated areas. Domestic travel is required on occasion.