Quality Assurance Specialist

Quality Consulting Group, LLC · Juncos

New

🇬🇧 English

cGMP SAP MES EDMQ DQMS TrackWise computer systems validation

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 49 minutes ago

Expires 1 month from now

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Quality Consulting Group, LLC

Juncos

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