Quality Engineer

Shire Pharmaceuticals, Inc.Founded in 1986, Shire Pharmaceuticals Inc. is a global specialty pharmaceutical company. Our mission is to develop and market medicines that improve the quality of life for patients and their caregivers.Shire succeeds because of our people. Through teamwork, commitment, innovative thinking and energy, Shire will continue to grow as a world-class pharmaceutical organization. Due to our extended growth, we currently have a need for the following position:Act as first responder for quality issues; manage and guide the response, actively pursuing resolution. Review and issue final approval on various procedural documents and reports. Ensure regulatory and procedural compliance throughout all activities. Represent site and corporate QA in interactions with other departments.? Act as first responder for quality issues and actively pursue fast, compliant closure and documentation of all non-conformance reports (NCRs) and corrective and preventative action (CAPA) implementations. ? Provide quality assurance (QA) input and documentation to support quality and compliance decisions as well as material disposition decisions.? Act as site QA reviewer for quality investigations, deviations and CAPA with limited approval authority as designated by QA Management.? Act as site QA reviewer for SOPS, protocols, and reports related to projects.? Participate in site and corporate quality & process improvement initiatives.? Acting as site QA representative on project teams and represent corporate perspective as necessary.? Manage completion of tasks assigned to QA; provide quality and compliance expertise for the team as necessary.? Support and participate in compliancecritical efforts including change controls and validation processes.? Perform trend analysis and report results for key quality metrics.? Provide support for continuous improvement initiatives.? Support regulatory/client audits of site.Shire is committed to providing high quality, competitive, and appropriate health care benefits for employees and their families.Shire is an Equal Employment Opportunity and Affirmative Action Employer.Requirements: ? Bachelor?s degree in Science, Engineering, or Pharmaceutical studies? Minimum of 5 years quality assurance experience in a pharmaceutical company? ASQ CQE desired? Knowledge of solid dosage manufacturing desired? Strong knowledge of 21-CFR-210, 21-CFR-211 ? Clear problem-solving and decision-making skills? Ability to function well under pressure in a changing environment? Computer literate with a working knowledge of SPCApply to Shire