Biomat USA, Inc. Quality & Compliance Specialist in Raleigh, North Carolina
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
This position is based out of our Los Angeles CA, Seattle WA, or Raleigh NC Headquarters and is a Hybrid work schedule.
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.
Candidate must understand the Code of Federal Regulations (CFR) as it applies to Source Plasma.
Candidate 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).
Positon requires substantial travel.
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. 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
Req ID: 478167
Type: Indefinido tiempo completo
Job Category: Calidad