Manufacturing Quality Specialist (2nd Shift)
EurofinsLouisvilleFull TimeEngineering
Remotely
quality assuranceroot cause analysiscapaiso 9001iso 13485quality audits21 cfr 820nonconformance
Job Description
📋 Description
- Implement process controls and audits in oligo manufacturing.
- Collaborate with cross-functional teams to ensure regulatory compliance.
- Support customer complaints and product returns investigations.
- Back-up QC technician and perform final QC checks on VIP orders.
- Conduct manufacturing process audits for risk and compliance.
- Lead CAPA investigations and track corrective actions.
🎯 Requirements
- Bachelor's in engineering, Life Sciences, Chemistry, or related field; Master’s preferred.
- 3+ years in quality assurance/manufacturing quality control in regulated industry.
- Working knowledge of 21 CFR 820, ISO 9001, ISO 13485.
- Experience with quality audits, nonconformance management, root cause analysis.
- Strong problem-solving skills and CAPA leadership.
- Excellent attention to detail and cross-functional collaboration.
🎁 Benefits
- Schedule: Tue-Sat, 3 PM-12 AM.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
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