GMP Manufacturing Specialist – Quality & NPI Support

Quality Consulting Group

Juncos (PR)

Presencial

USD 75.000 - 110.000

Jornada completa

Hace 3 días

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Descripción de la vacante

Quality Consulting Group, LLC, a leader in pharmaceutical, biotech, medical devices, and manufacturing, seeks a talented manufacturing operations professional to join our team in Puerto Rico and the USA. You will support manufacturing and quality systems, drive process improvements, and collaborate with cross-functional teams to ensure compliant operations.

The role emphasizes on-the-floor support, NC/CAPA investigations, change control, and participation in process validation activities, with

Formación

Bachelor’s degree in a relevant field and 4+ years in manufacturing operations.
Direct pharmaceutical/biotech manufacturing experience.
Hands-on GMP floor support experience.
Experience with NC/CAPA investigations and closure.
Process validation protocols, execution, and data analysis.

Responsabilidades

Support manufacturing and quality systems, including non-conformances and process validation.
Serve as process owner for production support systems and SOPs.
Develop and revise manufacturing procedures to reflect current operations.
Monitor process performance through floor observations and data review.
Assist with NC/CAPA investigations and corrective actions.
Support NPI activities and CCRB packages.
Collaborate with cross-functional teams to resolve issues.
Prepare quarterly process monitoring reports.