Senior QA Specialist, cGMP Quality & Compliance

Fagron Tech; Canton (MA); Presencial; USD 120.000 - 150.000; Jornada completa

Descripción de la vacante

Fagron US is seeking a Quality Assurance Senior Specialist to advance cGMP manufacturing quality, documentation, and product disposition for compounded products.

The role requires leading Level 1–3 QA activities, ensuring ALCOA-compliant records, and supporting audits. You will collaborate across manufacturing, QA, and regulatory teams, demonstrate SME in at least two QA functions, and drive improvements in batch records, change controls, and deviation handling.

Formación

• College Degree and 8–10 years cGMP experience in pharma manufacturing or equivalent.
• Experience with quality systems, aseptic technique and cGMP document review.
• Preferred: CAPA, Change Control and MasterControl familiarity.

Responsabilidades

• Execute Level 1–3 QA tasks including line clearances, label review and logbook reconciliations.
• Issue and review batch records; approve testing data and event reports.
• Disposition and release of incoming materials and finished product.
• Document control activities and approval of change controls.
• Support quality investigations, deviations, and corrective actions.
• Assist inspections and audits; ensure ALCOA-compliant documentation.
• Maintain training SOPs and participate in additional duties as needed.

Conocimientos

Quality systems

Aseptic technique

cGMP document review

Quality investigations

CAPA

Change Control

MasterControl

Educación

College Degree

Herramientas

MS Office

MasterControl

Descripción del empleo

Fagron US is seeking a Quality Assurance Senior Specialist to advance cGMP manufacturing quality, documentation, and product disposition for compounded products.

The role requires leading Level 1–3 QA activities, ensuring ALCOA-compliant records, and supporting audits. You will collaborate across manufacturing, QA, and regulatory teams, demonstrate SME in at least two QA functions, and drive improvements in batch records, change controls, and deviation handling.