Software Validation Associate

Job ID
1704
# of Openings
1
Job Type
Full-Time
Work Schedule
Monday-Friday, 8am-5pm
Job Category
Information Technology

Overview

For more than 20 years, AlloSource’s allografts have been the biologic solutions our surgeon customers use to deliver better care to their patients. As one of the largest and most respected nonprofit tissue banks in the United States, AlloSource develops, processes and distributes over 200 types of life-saving and life-enhancing allografts for use in a variety of medical procedures. Our commitment to honoring the gift of tissue donation motivates us to develop innovative allografts and lead the way in cellular and tissue therapies.

 

Summary

The Software Validation Associate is responsible for working with the company system owners and IT Department to complete the software validation activities required to meet company-wide validation requirements and ensure compliance to regulations. These activities include, but are not limited to: requirements specification creation, validation protocol development and execution, software testing, trace matrix and FMEA creation, deviation resolution and reports.

 

Essential Duties and Responsibilities:

  1. Works closely with the software system owners to develop requirements and manage the validation project with all cross-functional resources
  2. Develop and implement test scripts that support validation qualifications.
  3. Exercise good quality and regulatory judgment when executing daily job duties.
  4. Educate end user on the need-to-know aspects of software validation
  5. Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.

 

Requirements:

  • 1+ years experience in a software QA / QC environment
  • Proficiency in Microsoft Applications, specifically Excel, Word and Outlook
  • Associates degree – Computer Science, or other technical field
  • In lieu of degree, relevant college level study, work experience as it relates to the above responsibilities, and demonstrated technical aptitude may be substituted.
  • The position primary focus is on quality and regulatory compliance. Organization, attention to detail and strong writing skills are imperative in combination with an overall aptitude for understanding and using enterprise based software solutions.

 

Preferred Experience:

  • Executing validation documents
  • Report writing or similar technical work
  • Experience with test automation tools
  • FDA regulated work environment
  • Relevant Microsoft Certification

 

For consideration you must apply online, submit a current resume and meet the minimum requirements.  All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position.  Candidates within a 50 mile radius of the hiring zip code may receive first consideration.  If you require special accommodations, please contact us at 720-873-0213. 

 

EOE/Veterans/Disability 

 

 

AlloSource uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

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