AlloSource

Quality Excellence Expert - Processing

Job ID
2864
# of Openings
1
Work Schedule
Monday-Friday; 8am-5pm
Job Category
Engineering

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 Quality Excellence Expert – Processing will serve as the Department Subject Matter Expert for specific processes within the Quality System. The QEE makes decisions based upon knowledge, training, and experience, with regulatory compliance and the integrity of AlloSource at the forefront of consideration.  They manage and maintain specific departmental Quality System responses and contribute knowledge and expertise, specific to one or more assigned subject category(ies).

 

In addition to support for Quality System activities, this role also supports Production / Engineering activities. This support includes, but is not limited to, supporting the process owners and process improvement activities, supporting equipment/processes/systems, process/product engineering, documentation modification, and supporting equipment validation.  The QEE is expected to adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices, and company policies.

 

Pay:   $57,248 - $74,500/yr based on relevant years of experience

Bonus:  10% target Bonus Program based on individual and company metrics

Shift:  Monday-Friday; 8:00am – 5:00pm

Benefits:  Generous Time Off Policy, Paid Sick Leave, 9 paid Holidays, Retirement Plan, onsite Health Care clinic, Wellness Program, Life Insurance, AD&D, Short & Long Term Disability, and more!

Location:  6278 S. Troy Circle, Centennial, CO 80111

 

Essential Duties and Responsibilities:

  • Quality System Responsibilities:
  • Production Case ownership and support
  • Nonconformance Reports
  • Change Control
  • Complaints
  • Participate in internal and external audits to ensure system processes are operating in accordance with controlled procedures.
  • CAPA support (Corrective and Preventive Action Process)

 

  • Operations Responsibilities:
  • Provide hands on technical support for Engineering department projects and tactical business initiatives.
  • Support Continuous Process Improvements (CPIs)
  • Working with engineers, develop skills required to track tissue processing issues, identify trends, and develop root cause solutions.
  • Daily interface with manufacturing providing subject matter expertise.

 

  • Adhere to and promote proper practices and techniques which are consistent with current operating procedures, training requirements, safety practices and company policies.
  • May perform other related duties and responsibilities as assigned.

Requirements:

  • Bachelor’s degree
  • In lieu of degree, 7 years’ experience working in a regulated industry
  • 5 years’ experience working in Production
  • Successful completion of AATB Certification required within 1 year of accepting role
    • If already certified, evidence of certification
  • 5 years’ experience working with quality records in a regulated industry
  • 3 years’ experience writing/editing formal documents
  • Experience leading projects and/or continuous improvement initiatives
  • Proficiency in Microsoft Office applications

 

Preferred Experience:

  • AATB certification
  • Green Belt certification
  • Experience with Quality Assurance/Regulatory Affairs environment
  • Experience working within a Quality Management System
  • Experience with Minitab
  • ERP system experience

 

It is the policy of AlloSource not to discriminate against qualified individuals with disabilities in regard to application procedures, hiring, advancement, discharge, compensation, training or other terms, conditions and privileges of employment. When needed we will provide reasonable accommodations to qualified applicants and employees so that they may perform the essential job duties of the position. If you require special accommodations, please contact us at 720-873-0213. 

 

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.  AlloSource is a Fair Chance Employer.  Candidates within a 50 mile radius of the hiring zip code may receive first consideration.

 

Equal Opportunity Employer/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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