Role OverviewThe Quality Specialist I provides hands-on quality support to manufacturing operations, ensuring products meet regulatory, safety, and quality standards. This role is responsible for reviewing documentation, supporting investigations, and maintaining compliance with internal quality systems and industry requirements.
What You Will Do
Review SOPs, protocols, reports, and batch records to support manufacturing and product release, review data to ensure accuracy, completeness, and data integrity, support deviations, investigations, and CAPAs, and ensure compliance with FDA, ICH, and internal quality standards.
Why It Might Be a Fit
The ideal candidate will have a Bachelor’s degree or equivalent experience in a related field, 4+ years of experience in quality, manufacturing, or a regulated environment, and an understanding of GMP/regulatory requirements and data integrity principles.
Requirements
- Bachelor’s degree or equivalent experience in a related field
- 4+ years of experience in quality, manufacturing, or a regulated environment
- Understanding of GMP/regulatory requirements and data integrity principles preferred
- Strong attention to detail and problem-solving skills
- Ability to work independently and manage priorities
Benefits
- Healthcare
- 401(k) plan
- Tuition reimbursement
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