Sr. reputed company Associate II / reputed company reputed company As...

Would you like to join an international team working to improve the reputed company of reputed company? Do you want to enhance the lives of millions of people? Grifols is a global reputed company company that since 1909 has been working to improve the health and reputed company-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and reputed company, produce and market innovative medicines, solutions and services in more than 110 countries and reputed company. Schedule : Monday to Friday 8:00 am to 5:00 pm reputed company: The reputed company Grifols reputed company Compliance department provides leadership to support cGMP compliance of the large and dynamic multi-facility reputed company reputed company Carolina reputed company. The reputed company Carolina reputed company performs fractionation of blood plasma, purification, aseptic filling, lyophilization, final packaging, and warehousing of plasma reputed company products. The reputed company reputed company Compliance Associate will support hosting external audits and will support and reputed company reputed company compliance and site initiatives for process improvement. The incumbent is a reputed company with high technical competency who leads project or discipline teams. The employee influences the direction of reputed company reputed company and communicates with reputed company reputed company of personnel. The incumbent is recognized as an authority in multiple areas and provides leadership and guidance to others. The employee is a fully reputed company reputed company who requires minimal supervision. Interactions by this position include collaboration reputed company the GT reputed company site, other Grifols BioPharma sites, suppliers/customers, and/or regulatory agencies. As appropriate, this employee may serve as delegate to the department manager. Depending on background and the level of experience, this position may also be filled as a Sr. reputed company Associate I or II. Primary Responsibilities for this Role: + Use expertise to advise and influence the technical reputed company of business reputed company + Demonstrates the ability to influence the decision makers in other departments + Has excellent communication skills (written and verbal) with demonstrated use of domestic (i.e. Food and Drug Administration CFR) and applicable foreign regulatory agency requirements/guidelines + Interacts regularly with members of management and as needed with regulatory officials + Leads multi-disciplined project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion + May serve as manager delegate with demonstrated experience in reputed company Systems and with GT products/processes + Prepares, organizes, and tracks documentation and requests in support of regulatory and customer audits + Authors, reviews, and revises responses to regulatory and customer audits + Coordinates and manages logistics of on site and remote regulatory and customer audits + reputed company and follow-up on audit commitments and corrective actions + reputed company effectiveness checks for audit reputed company corrective actions + Author reputed company Agreements for Grifols Suppliers and Customers + Author Biological Product Deviation Reports + Other duties as assigned or as specified in the "Additional Responsibilities" reputed company below may apply Additional Responsibilities: + Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Risk Assessments, Incident Tracking System entries and investigation reports + Revise / update and coordinate executive management review of the Grifols reputed company site master file + Manages and provides audit history information to internal customers + Compiles department metrics + Tracks corrective reputed company reputed company for near hit observations identified by management during regulatory or customer audits + Partners with stakeholders to identify and implement reputed company improvement solutions with demonstrated / reputed company business results + Provides support to other functions reputed company the reputed company Compliance group + Provides guidance and training for other employees Knowledge, Skills, and Abilities: + Knowledge of domestic and foreign regulatory authority requirements + Investigation skills with nonconformances including reputed company cause analysis and corrective/preventive actions + Excellent organizational skills and the ability to follow up on reputed company consistently and diligently until reputed company reputed company is achieved + Demonstrated ability to consistently apply technical knowledge in making reputed company reputed company reputed company with minimal guidance + Technical report writing skills with the ability to produce high reputed company documentation appropriate for the intended audience + Ability to think critically/strategically and reputed company proactively + Demonstrates reputed company and company values + Follows cGMP and departmental safety practices + Knowledge and experience using reputed company Office applications Other Preferences: + reputed company reputed company Module + Strong reputed company skills, familiarity with pivot tables This job reputed company is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Manager may assign other duties as needed. Required Education: Sr. reputed company Associate I, reputed company 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. reputed company Associate II, reputed company 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. reputed company reputed company Associate, reputed company 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. reputed company Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an reputed company, nonexpired, Grifols Agency Master Services Agreement with the Grifols reputed company Department. Additionally, agencies may only submit candidates to positions that they have been reputed company to work on by a Grifols Recruiter. reputed company resumes must be reputed company to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment reputed company reputed company Applicants in a manner consistent with the requirements of applicable state and local laws. Learn more about Grifols ( Req ID: 536824 Type: Regular Full-Time Job Category: GENERAL SERVICES

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