Would you like to develop your skills working for a mission-driven organization while playing an important role in leading the way in Life Sciences? AlloSource is a BioTech company headquartered in Centennial, Colorado.

Here at AlloSource we’re not looking for jobseekers. We want people dedicated to our mission of restoring hope to donor families, and helping patients heal through our innovative cellular and tissue allografts. This takes a special person with a strong desire to help make a tremendous impact on people’s lives. Regardless of which department you work in at AlloSource, we value your efforts, your top-notch skills, and your abilities to contribute to our ultimate goal of saving or enhancing human life! What better reward is there than knowing you contributed, in some way, to save or enhance a person’s life! If this sounds like an organization you wish to be a part of, then we invite you to apply.

Summary

The Software Validation Supervisor is responsible for the overall operational performance of the Software Validation team. This includes overseeing software validation activities necessary to meet companywide requirements and ensure compliance with FDA regulations, AATB rules, ISO, quality policy and internal procedures. Provide oversite for the Master Software Validation Plan. Continuously improving standards, quality, reporting, and related processes.

Anticipated Application Deadline May 8, 2025 (100PM MST)

Pay $83,282 - $101,656/yr. based upon relevant years of experience

Shift Monday -Friday; 800am to 500pm (Hybrid work schedule; 3 days in the office, 2 days from home)

Benefits Medical, Dental, Vision, Life Insurance. Click link for more benefits details AlloSource_BenefitGuide-20241023195437.pdf

Location 6278 S Troy Circle Centennial, CO 80111

Essential Duties and Responsibilities

• Act as the key liaison between IT and Regulatory Affairs including client and compliance agency audits related to software validation.
• Manage partnership with cross functional business units and key stakeholders to develop system requirements that supports the software validation processes and solutions.
• Facilitate the development of best practices, standard operating procedures, forms, and policies to maintain compliance and data consistency.
• Participate in Failure Investigations, Nonconformance Reports, Corrective / Preventive Actions related to software functions.
• Develop and implement validation protocols/reports (IQ, OQ, PQ) for software.
• Maintain, update, and develop software validation documentation as needed (standard processes, decision trees, work instructions, job aids, etc.).
• Develop, implement, and train staff on Software Validation strategies and approaches to meet the requirements of 21 CFR Part 11 that withstands audit scrutiny.
• Provide workforce leadership and direction in the daily activities of the Software Validation team.
• 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, 7years' quality compliance management with a regulated industry
• 3-5 years' software QA/AC experience within a regulated industry
• 2+ years’ experience testing in a multi-platform environment.
• 1 or more years leading projects, continuous improvement initiatives
• Proficiency in Microsoft Office applications
• Demonstrated proficiency in developing policies, processes, and protocols to support company programs
• Ability to communicate in English proficiently (speaking, reading, writing, and comprehension)
  
  
  

Preferred Experience

• 1 or more years of supervisory experience
• 1 or more years of experience authoring and executing validation documents
• Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11
• Certified auditor, OR equivalent experience conducting software vendor quality audits
  
  
  

Click Link for Full Job Description Software Validation Supervisor

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

Equal Opportunity Employer -All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws.

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.