Role OverviewThe Quality Assurance Specialist I will provide support during regulatory inspections, plan and present Quality System information, and maintain Quality Systems policies to ensure regulatory compliance.
What You Will Do
The Quality Assurance Specialist I will initiate, review, and approve Change Controls, Recalls, Deviations, and CAPAs, and assist in external audits.
Why It Might Be a Fit
The Quality Assurance Specialist I will participate in cross-functional initiatives, assist in validation projects, and be able to professionally communicate with customers/clients.
Requirements
- Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field
- Minimum of 1-3 years' experience in a quality, preferably a logistics role
- Strong understanding of a 3PL business, audits, and complaints procedures
- Validation and DEA experience
- Medical Device, Pharma, and Plasma experience
- Experience in temperature monitoring of controlled environments
Benefits
- Dental insurance
- Vision insurance
- Life insurance
- Medical, dental, and vision insurance for employees and dependents
- 401(k) plan
- Paid time off
- Vacation days
- Sick leave
- Holidays
- Travel up to 10%
- Training – public speaking
- Certified auditor training per ASQ or ISO (preferred)
- Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred
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