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Sr. IT Quality Control Specialist - Remote US
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Job Description
- Req#: JR0142177
Employer Industry: Oncology Research
Why consider this job opportunity:
- Opportunity for career advancement and growth within the organization
- Remote position allowing for work flexibility within the U.S.
- Competitive compensation package including potential annual bonuses
- Comprehensive benefits to support physical, mental, and financial well-being
- Be part of a mission-driven organization making a difference in cancer treatment and research
What to Expect (Job Responsibilities):
- Provide expert guidance on regulatory requirements related to software validation, quality management, and GxP compliance
- Review validation lifecycle documentation for completeness and alignment with standards and regulations
- Deliver quality oversight during the preparation, execution, data analysis, and reporting of validation protocols
- Conduct periodic reviews of system documentation to maintain compliance with corporate policies and regulatory expectations
- Perform quality review and approval of change control documentation impacting validated systems or processes
What is Required (Qualifications):
- Bachelor's Degree highly preferred; relevant work experience may substitute for education
- 3-5+ years of work experience in clinical research, life sciences, or CRO focused on FDA GxP requirements
- Experience with industry standards for software quality such as GAMP V, PIC/S, and ICH
- Knowledge of pharmaceutical, biologics, CRO, and/or medical device industry regulations
- Exceptional time management and organizational skills, with experience in cross-disciplinary teams
How to Stand Out (Preferred Qualifications):
- Experience with software validation principles and FDA software validation guidelines
- Familiarity with community-based clinical trials and oncology research
#OncologyResearch #ClinicalTrials #RemoteWork #CareerOpportunity #CompetitiveCompensationAbout the company
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