QA Specialist

Autore :


settore :

Settore farmaceutico

Figura professionale :

Specialista Qualità

luogo :

Morris Plains, U.S.

Tipo di contratto :

Tempo indeterminato

Orario di lavoro :

Tempo pieno

Stipendio :

Retribuzione lorda 25000.00 - 35000.00 all'anno


QA Specialist – Contract or CTP – Morris Plains, NJ

Role Description

The Quality Assurance delivers on the client's commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

The Quality Assurance on the floor is responsible for coordinating, managing on the floor Quality Oversight within commercial Drug Product operations to ensure sustained compliance with GMPs and regulatory readiness.

• Provides Quality oversight to operations on the shop floor. Supports manufacturing operations (upstream and downstream) at real time.

• Assists and advises on pertinent quality issues as they arise during plant operations.

• Troubleshoot and elevate noncompliance issues and events observed.

• Demonstrates knowledge of investigation, CAPA, and corrective action processes.

• Demonstrates ability to effectively prioritize and manage multiple project workloads

• Ensures compliance to policies and procedures

• Maintains and supports material inventory, status and transfers.

• Performs and supports changeovers in production area as required.

• Participates in audits and other projects as appropriate.

• Supports manufacturing operations (upstream and downstream) and staff as needed to identify and address product quality and compliance issues as they arise.

• Reviews documentation associated with production operations. Ensures adequate levels of documentation are acceptable and compliant to existing procedures.

• Participates in process improvement initiatives targeting for Right First Time (RFT) on documentation.

• Participates in activities associated with event resolution and CAPAs, with a focus on organizing and attending cross-functional meetings.

• Implements and ensures adherence of appropriate regulations and quality standards.

• Supports operations to encourage a Quality Culture and ensure a safe working environment.

• Completes job-related training as required.

Skills & Requirements

• 2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.

• Prior experience in pharmaceutical industry is preferred.

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