Overview
Associate Quality Control, Environmental and Utilities Monitoring Jobs in Holly Springs, NC at Amgen
Job Description:
Join a leading biomedical software development project and provide Quality Assurance oversight throughout the Software Development Life Cycle (SDLC), ensuring compliance with regulatory standards (FDA/GMP). You’ll act as a QA subject matter expert on cross-functional teams.
Responsibilities:
Provide QA oversight and regulatory compliance across software development and validation phases.
Review project documentation: requirements, designs, test plans/cases, and summary reports.
Identify and resolve software defects and develop CAPAs.
Act as internal QA advisor across teams.
Lead/participate in cross-functional process improvement efforts.
Monitor evolving biomedical regulatory standards.
Approve internal procedures to ensure regulatory compliance.
Requirements:
Bachelor’s degree (required).
10–15 years of QA experience, ideally in a medical device or FDA-regulated environment.
In-depth knowledge of SDLC, risk management, and configuration management.
Excellent written and verbal communication skills.
Able to collaborate effectively in cross-disciplinary teams in a fast-paced setting.
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Title: Associate Quality Control, Environmental and Utilities Monitoring
Company: Amgen
Location: Holly Springs, NC
