Quality Engineer - Cambridge, United States - BioTalent

Description

BioTalent are supporting a world leader within advanced therapies who are searching for a Quality Engineer II to join their facility in Massachusetts.

You will be responsible managing the Quality Systems, working closely with subject matter experts to facilitate the development and continuous improvement, ensuring implementation in compliance with regulations, procedures and policies.

This role will offer you:
To join a high growth company with a strong portfolio working along a team of professionals who are committed to improving the lives of the patients
A great opportunity to develop your career within a company that provides continuous career and development opportunities
To report into senior upper management with significant exposure to projects


You will be Responsible for:
Quality System activities including Change Controls, Design Controls, Product Reviews, ensuring Inspection Readiness, and Risk Management
Ensuring compliance with company procedures and industry standards in support of cell therapy products.
Writing and improving procedures to ensure operations meet cGMP regulations / internal SOPs and company policies.
Managing quality standards and procedures for quality systems.
Reviewing cGMP documents and supporting/leading implementation of systems


You will bring the following:
Bachelor's Degree in Science or Engineering preferred
Strong QA experience within the Biotech / Pharmaceutical industry
Design Control and Change Controls experience
Risk management and FMEA experience
Strong experience working within a GMP compliant manufacturing facility

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