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Principal Specialist - IT Quality
Job in
Coos Bay, Coos County, Oregon, 97458, USA
Listed on 2026-01-12
Listing for:
KBI Biopharma
Full Time
position Listed on 2026-01-12
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Employer Industry: Biopharmaceutical Development and Manufacturing
Why consider this job opportunity- Salary range up to $ per year
- Opportunity for career advancement within a global leader in biopharmaceutical development
- Work in a dynamic environment that supports innovation and scientific breakthroughs
- Engage in quality oversight and compliance in a regulated manufacturing setting
- Be part of a diverse and inclusive workforce that values all perspectives
- Audit and manage process improvements across the employer's IT infrastructure
- Provide oversight and quality authority for IT compliance‑related SOPs and policies
- Review and approve all software administrative SOPs within the global network
- Serve as the global quality approver for IT‑related CAPAs, change controls, and deviations
- Ensure compliance with cGMPs and regulatory requirements for IT infrastructure
- Bachelor’s degree with 8+ years of experience or Master’s degree with 6+ years of experience in a QA or GMP environment
- Advanced knowledge of IT infrastructure best practices in a pharmaceutical setting
- Experience in data integrity, computer system validation, and IT quality in an FDA‑regulated manufacturing environment
- Demonstrated expert knowledge of 21 CFR Part 11 and EU Annex 11
- Experience in a contract development and manufacturing organization (CDMO)
- Familiarity with regulatory compliance and validation processes in biopharmaceuticals
- Strong analytical and problem‑solving skills in a quality assurance context
- Previous experience working with cross‑functional teams in a global environment
#Biopharmaceuticals #Quality Assurance #ITCompliance #Career Opportunity #Diversity And Inclusion
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