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Compliance Audits Manager
POCATELLO ID 83206
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90439577

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Grifols Shared Services North America, Inc

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Summary

  Job posted:   Sat Jun 2, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
Compliance Audits Manager
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.










**_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]]**





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