Job: Software Validation Associate
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Jobing Description
AlloSource is a non-profit organization founded in 1994 on a promise: to honor and respect the gift of donation by responsibly developing, processing and distributing life-saving and life-enhancing allografts for its communities. We deliver on this promise 24/7/365 with safe, effective and innovative allografts.
We strive to be the tissue network patients and the world's most respected transplant teams ask for by name. This is accomplished not only by offering more than 200 standard and customized precision allograft products, but also by being trusted, valued, knowledgeable partners to the medical community as well as to patients and donor families.
We are inspired every day by the patients we help and the donors we honor.
If you are looking for a challenging, fulfilling and rewarding career at a highly regarded, growing medical organization, AlloSource offers exceptional career opportunities with competitive compensation and outstanding benefits. In fact, AlloSource was chosen by the Society for Human Resources Management as one of the Best Companies to Work for in Colorado in 2007 and 2008.
As one of Americas leading non-profit tissue networks, and one of the worlds largest suppliers of fresh cartilage allografts and skin used for life-saving burn applications, AlloSource is the one organization where employees find a truly energized corporate culture, a commitment to enhancing lives, and a compelling career with advancement opportunities.
AlloSource is currently seeking a Software Validation Associate to join our outstanding team.
Position Summary:
Working with the company system owners and IT Department, 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, program SOP creation and maintenance, deviation resolution and reports. This position will also act as the main contact for compliance agencies and audits.
Essential Duties And Responsibilities:
* Works closely with the software system owners to develop requirements and manage the validation project with all cross-functional resources
* Develops standard operating procedures, forms, policy and validation package documentation to improve and provide consistency on company procedures in support of company software validation program
* Develop and implement validation protocols/reports (IQ, OQ, PQ) for software.
* Develop an interpretation for meeting the requirements of 21 CFR Part 11 that withstands audit scrutiny
* Participate in Failure Investigations, Nonconformance Reports, Corrective / Preventive Actions.
* Act as the main point of contact for client and compliance agency audits.
* Exercise good quality and regulatory judgment when executing daily job duties.
* Educate end user on the need-to-know aspects of software validation
Skills / Requirements
Education/ Formal Training Required:
* Associates degree in IT or other technical field.
Job and Industry Experience Required:
* 1 year experience in a FDA regulated environment working in a validation role - software, equipment or process.
Job and Industry Experience Preferred:
* Tissue banking, medical device or pharmaceutical preferred
Important Notes
If you are seeking a challenging career opportunity in a growing organization, click on the "APPLY HERE" link listed below. This will direct you to the job posting on the AlloSource career site.
Reference that you found this fantastic career opportunity on the Jobing.com network of employment websites.
NOTE: For consideration you must submit a resume by position close date and meet minimum requirements. All offers are contingent upon a background check and drug screen. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-4763.
AlloSource offers equal opportunity employment to all qualified employees and applicants for employment without regard to race, creed, color, sex, national origin, age, disability or veteran status. Most of our employment opportunities are posted internally for employees consideration. AA EOE
