Grifols Jobs

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Job Information

Grifols Shared Services North America, Inc Quality & Compliance Specialist in los angeles, California

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Primary responsibilities for the role:

  • 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.

EEO Minorities/Females/Disability/Veterans

Learn more about Grifols

Req ID: 123607

Type: Regular Full-Time

Job Category: Quality