Alphanumeric is hiring a QA SPECIALIST - Level 2 to work first shift in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Pay range: $55 - $61
We are seeking a highly skilled and experienced Senior QA Specialist to join our dynamic team. In this role, you will be responsible for overseeing the quality assurance process, ensuring that our products meet both Local and Global quality standards.
Responsibilities:
* Execute all activities following quality and regulatory standards and procedures.
* Promote a quality mindset and quality excellence approach to all activities.
* Provide on the floor support to Manufacturing activities.
* Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
* 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.
* Review and approve Standard Operating Procedures, logbooks and QC data.
* 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, as necessary.
* Support SAP integration and master data migration, as applicable.
* 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.