Grifols Shared Services North America, Inc Compliance Audits Manager in Moorhead, Minnesota

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.

Please note: this is a remote position

Provide support to donor center operations, quality and training groups by conducting donor center, warehouse, transportation and lab and other suppliers of services and goods auditing activities inspecting for compliance with regulatory and customer requirements and to Standard Operating Procedures (SOP) and current Good Manufacturing Practices (cGMP).

  • Assess facility compliance with SOPs, applicable domestic regulatory agencies such as FDA, international regulatory agencies such as EMA, federal and state regulations.

  • Assess overall facility performance with regard to general operations, such as but not limited to; organization, employee training and cleanliness.

  • Prepare and present electronic report of inspection findings with comments to inspected facility, designated corporate directors, appropriate Operations, Quality and Training managers as well as other appropriate persons as requested.

  • Interact with facility management and other members of donor center management to assure understanding of audit findings.

  • Provide support, suggestions and ideas about improving problem systems to facility employees.

  • Analyze and evaluate reports prepared by facilities in response to audits performed. Evaluate for adequacy of corrective actions, completeness of report and close audit when satisfactorily completed.

  • Assist in development of new or revised procedures based on trends, audit findings, interaction with facilities. Recommend corporate-wide solutions or operational changes as necessary.

Requirements/Skills

  • Bachelor’s degree

  • At least two years practical post-graduate experience related to the collection and/or testing of human blood and blood components, preparations, storage and distribution. Previous experience should demonstrate expertise in SOP development as well as an understanding of quality control principles and QA audit function.

  • Proficient in Microsoft Office suite with emphasis in Word and Excel. Ability to articulate clearly and deliver oral presentations. Solid writing and reporting skills required. Expert knowledge in cGMPs, FDA, CLIA, IQPP and European regulations.

  • Participate in Quality and Compliance related presentations for the Grifols Plasmapheresis Academy as needed

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 70873

Type: Regular Full-Time

Job Category: Quality