QA Senior Specialist - Katalyst Healthcares & Life Sciences
Cambridge, MA 02138
About the 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.
- Provide on the floor support to Manufacturing
- 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.
Requirements:
- Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
- Demonstrated experience in regulatory inspection activities.
- Ability to work on multiple projects on a tight timeline.
- Ability to prioritize and the flexibility to adapt to changing priorities.
- Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- Experience working successfully both independently and in a team environment.
- Strong verbal and written communication skills.
- Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility operations, validation, production, and QC.
- Able to prioritize and decide appropriate course of actions.
- Root cause analysis experience preferred.
Source : Katalyst Healthcares & Life Sciences