Quality Assurance Specialist
Quality Consulting Group, LLC · Juncos
Job description
About the role
QUALITY CONSULTING GROUP is seeking a motivated Quality Assurance Specialist to support cGMP manufacturing operations in Puerto Rico and the United States. You will work with cross‑functional teams to ensure product quality, regulatory compliance, and continuous improvement.
Key responsibilities
- Perform on‑floor Plant Quality Assurance reviews, approve batch records, MES/EBR, SAP, EDMQ, DQMS, and TrackWise documentation.
- Triaged, investigated, and resolved deviations, CAPAs, and quality events in line with cGMP requirements.
- Support change control, validation, new product introduction, and internal/external audits.
- Analyze quality data, lead continuous‑improvement projects, and communicate risks to management.
Required profile
- Bachelor's degree in Science or Engineering.
- Experience in QA within pharmaceutical, biotech, or medical device manufacturing.
- Strong knowledge of cGMP, quality systems, deviations, CAPA, change control, and validation.
- Fluent written and verbal English and Spanish.
Required skills
- cGMP compliance
- SAP
- MES/EBR
- EDMQ
- DQMS
- TrackWise
- Computer systems validation
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Published 10 hours ago
Expires 1 month from now
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Quality Consulting Group, LLC
Juncos
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