QA Specialist

Proclinical is seeking a QA Specialist for a global biopharmaceutical company located in Cambridge, MA.

In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.

Must be eligible to work in the US.

Job Responsibilities:

• Execute all activities following quality and regulatory standards and procedures.
• Promote a quality mindset and quality excellence approach to all activities.
• Continue support of continuous improvement culture and industrial excellence methodologies.
• Support employees and respective departments in a manner which is clear in approach, communication, and action.
• Provide proactive communication to customers to ensure timely escalation and resolution of issues. Follow up on issues to ensure completion in a timely manner. Support cross functional communication in all manners.
• Support batch release of drug substance including compilation of documentation
• Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
• Support SAP integration and master data migration for batch release activities
• Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
• Support GMP compliance and inspection readiness within organization. Assist in coordination of work for the QA Operations team to facilitate timely release of product lots.

If you are having difficulty in applying or if you have any questions, please contact Jillian Gnap at +(1) 215-660-3121 or j.gnap@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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