Jobs · Management · Indiana

Quality Client Representative

QvalFocus Inc. · Bloomington, IN · 1 wk ago
On-siteManagementContract
Quality Client Representative 6+ months temp to perm Bloomington, IN Role The Quality Client Representative is a member of the core client team and interacts directly with clients. The Quality Client Representative is responsible for all quality aspects of the project and provides exemplary customer service to both internal and external customers by focusing on quality and compliance. This position reports to the Quality Manager. Responsibilities Primary quality contact for assigned clients externally and internally.Manages client project quality updates and reviews with all levels of management.Responsible for making and delivering accurate and timely quality decisions pertaining to client projects, questions, and quality requests.Escalates quality issues to impacted departmental quality manager and/or Quality Director as necessary for corrective action implementation.Partners with manager and Quality leadership staff to author, drive or approve applicable quality documents, as the Quality representative in a timely manner.Partners with Program Manager, Technical Services Representatives, Quality Control Representative and Manufacturing Representative to coordinate projects, provide support, align facility representation, and provide consistent quality information.Represents Quality in required Project Client Meetings.Understands the quality and technical requirements of each project.Maintains Project File, including recording and tracking quality interaction with client. Track, trend, compile, and report client quality metrics as necessary.Thoroughly understands the Quality Agreement, Master Batch Record (MBR), Quality Control Master Document (QCMD), Regulatory and Procedural requirements that govern the client/company relationship and product.Create Annual Product Quality Reviews (APQRs)Assist and lead quality agreement contract negotiationsIdentifies and leads continuous improvement activities to maximize business results. Requirements Bachelor s degree required, preferably in a science related field with 5+ years pharmaceutical industry experience or a Master's degree with 3+ years of pharmaceutical experience.Familiar with quality operating procedures, quality, and regulatory requirements pertinent to pharmaceutical, biological and biochemical quality.Knowledge of worldwide regulatory requirementsComputer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

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