Quality Assurance Specialist I
On-siteAtlanta, Georgia, United States
Job Summary
Conduct regulatory inspections and audits for FDA, DEA, and State agencies while managing change controls, recalls, and deviations. Maintain quality systems and procedures through internal and external audits, root cause analysis, and SOP revisions. Release quarantined product and generate temperature reports using WebCTRL, ISM rotation, and Hold/Release processes. Participate in cross-functional initiatives, validation projects, and Gemba walks applying Six Sigma concepts. Communicate quality system information to internal and external groups. Work in a typical office environment with 25% warehouse time, requiring occasional lifting of 25-50 lbs and up to 10% travel.
Required Qualifications
- Must be able to successfully pass all preliminary employment requirements (i.e., background check and drug screen)
- Must be able to travel up to 10%
- Must have a valid driver's license
- Must be able to safely conduct occasional lifting of 25 - 50 lbs
- Must be able to read at a distance, close to the eyes, and at arm's length with or without correction
Desired Qualifications
- Bachelor of Science (BS) degree in Engineering, Science, Logistics, or related field preferred
- Minimum of 1-3 years' experience in a quality, preferably a logistics role
- Strong understanding of a 3PL business, audits and complaints procedures is preferred
- Validation and DEA experience strongly preferred
- Medical Device, Pharma, and Plasma experience preferred
- Experience in temperature monitoring of controlled environments
- Certified auditor training per ASQ or ISO (preferred)
- Demonstrated skills and practice of Six Sigma/statistics and process capability/FMEA is preferred
- Conversant with cGMPs, Quality Systems and CAPAs per 21 CFR 210/211 and 820
- Verifiable aptitude of FDA, OSHA, and DEA regulations
- Intermediate public speaking and presentation skills
- Excellent verbal and written communication skills
- Deftly navigate through Quality and Warehouse Management Systems with training – COMPLIANCE QUEST, Tecsys Elite, WebCTRL
- Intermediate Microsoft Office skills: Outlook, Excel, PowerPoint
- Training – public speaking
- Ability to take Constructive Criticism
- Interest in working in a fast-paced environment
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