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.

Apply (by clicking the relevant button) after checking through all the related job information below.

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