Grifols Shared Services North America, Inc Quality and Compliance Specialist in RTP, North Carolina
Grifols is a global healthcare company whose mission is to improve the health and well being of people. Our three divisions –Bioscience, Diagnostic and Hospital–develop, produce and market our innovative products and services to medical professionals in more than 100 countries.
We are committed to fostering an environment that creates continuous learning opportunities and encourages professional development and growth. As a company devoted to improving the health and well-being of people, we are looking for talented professionals worldwide. Make a difference and join us in this challenging and rewarding enterprise.
We’re Grifols, an international plasma manufacturer headquartered in Barcelona, Spain. We serve healthcare professionals and patients in over 90 countries, have an unmatched record of product safety, and are the largest plasmapheresis company in the world. We offer full healthcare benefits, tuition reimbursement, and some of our Academy courses even count for college credit! A career path at Grifols offers tremendous advantages in terms of doing exceptionally meaningful work in the healthcare field, learning new skills via our career progression programs, and enjoying full benefits for all of our full-time employees.
Coordinate and/or complete Site Master Files (SMFs)
Possess strong written and verbal communication skills that are required for crafting, writing, reviewing and/or approving responses and CAPA plans.
Provide on-site support during inspections by European regulatory authorities.
Assist the plasma group in maintaining operations that are compliant with European regulations.
Recognize areas of improvement and offer solutions to enhance compliance with European regulations.
Coordinate and/or complete responses to audits by European regulatory authorities.
Assist the Plasma Master File (PMF) holder in gathering information necessary to update regulatory authorities.
Act as a liaison to Biomat S.A. regarding compliance with European regulations.
Maintain various databases necessary to assure on-going activities are correct and appropriate.
Identify trends in regulatory observations.
Provide reports in various forms to various audiences to keep the plasma organization informed of activities occurring with regard to European compliance.
Interface with various levels and groups (social and economic) throughout the organization
Manage multiple tasks with competing demands and deadlines
Assess internal corporate audits to provide continuous surveillance of plasma suppliers to Biomat S.A.
BS degree is required, with a preference for an MS degree in a life science field. 4 years of directly related experience. They must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma. They must know the European Pharmacopoeia (EP) as it applies to Source Plasma and the interaction between the CFR, the EP and the company's SOP manual(s).
Please note that this position will be based in our LA, CA office.
We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Learn more about Grifols at http://www.grifols.com/es/web/international/home