Sr. Quality Associate II

Sr. Quality Associate II / Principal Quality Associate, Quality ComplianceLocation: NC-Clayton, USSchedule: Monday to Friday 8:00 am to 5:00 pmSummary:The Clayton Grifols Quality Compliance department provides leadership to support cGMP compliance of the large and dynamic multi-facility Clayton North Carolina campus. The North Carolina campus performs fractionation of blood plasma, purification, aseptic filling, lyophilization, final packaging, and warehousing of plasma related products. The Principle Quality Compliance Associate will support hosting external audits and will support and lead quality compliance and site initiatives for process improvement.The incumbent is a professional with high technical competency who leads project or discipline teams. The employee influences the direction of complex projects and communicates with all levels of personnel. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee is a fully qualified professional who requires minimal supervision. Interactions by this position include collaboration within the GT Clayton site, other Grifols BioPharma sites, suppliers/customers, and/or regulatory agencies. As appropriate, this employee may serve as delegate to the department manager.Primary Responsibilities for this Role:Use expertise to advise and influence the technical decisions of business unitsDemonstrates the ability to influence the decision makers in other departmentsHas excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelinesInteracts regularly with members of management and as needed with regulatory officialsLeads multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completionMay serve as manager delegate with demonstrated experience in Quality Systems and with GT products/processesPrepares, organizes, and tracks documentation and requests in support of regulatory and customer auditsAuthors, reviews, and revises responses to regulatory and customer auditsCoordinates and manages logistics of on site and remote regulatory and customer auditsTrack and follow-up on audit commitments and corrective actionsPerform effectiveness checks for audit related corrective actionsAuthor Quality Agreements for Grifols Suppliers and CustomersAuthor Biological Product Deviation ReportsOther duties as assigned or as specified in the "Additional Responsibilities" section below may applyAdditional Responsibilities:Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Risk Assessments, Incident Tracking System entries and investigation reportsRevise / update and coordinate executive management review of the Grifols Clayton site master fileManages and provides audit history information to internal customersCompiles department metricsTracks corrective action resolution for near hit observations identified by management during regulatory or customer auditsPartners with stakeholders to identify and implement continuous improvement solutions with demonstrated / measured business resultsProvides support to other functions within the Quality Compliance groupProvides guidance and training for other employeesKnowledge, Skills, and Abilities:Knowledge of domestic and foreign regulatory authority requirementsInvestigation skills with nonconformances including root cause analysis and corrective/preventive actionsExcellent organizational skills and the ability to follow up on matters consistently and diligently until timely resolution is achievedDemonstrated ability to consistently apply technical knowledge in making sound quality decisions with minimal guidanceTechnical report writing skills with the ability to produce high quality documentation appropriate for the intended audienceAbility to think critically/strategically and act proactivelyDemonstrates integrity and company valuesFollows cGMP and departmental safety practicesKnowledge and experience using Microsoft Office applicationsOther Preferences:SAP Quality ModuleStrong Excel skills, familiarity with pivot tablesThis job description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager may assign other duties as needed.Required Education:Sr. Quality Associate I, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.Sr. Quality Associate II, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.Principal Quality Associate, Quality Compliance: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 8 years relevant experience. A minimum of a BA/BS degree is required.Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.