Quality Specialist I
$90,000–$107,000 year
On-siteBethlehem, Pennsylvania, United States
Bethlehem, Pennsylvania, United StatesOn-siteFull Time$90,000–$107,000 yearBachelors DegreeEnterprise
Full TimeBachelors DegreeEnterprise
Job Summary
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, including review of reports. Ensure compliance with FDA, ICH, and internal quality standards. Provide oversight for equipment and software qualification, validation, and calibration activities. Partner with quality and cross-functional teams to maintain compliance and standardized processes. This role is onsite M-F 8am to 5pm with a pay rate of $90,000–$107,000 annually.
Required Qualifications
- Bachelor's degree or equivalent experience in a related field
- 4+ years of experience in quality, manufacturing, or a regulated environment
Desired Qualifications
- Understanding of GMP/regulatory requirements and data integrity principles preferred
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