Quality Assurance Specialist

4 days ago


Columbus, Ohio, United States Actalent Full time

The Quality Assurance Specialist will lead a newly formed CDMO quality assurance team, collaborating with internal and external partners to drive exciting science and innovation.

This critical QA role involves managing validations related to manufacturing product, process, equipment, laboratory, and facility, contributing to the oversight of key strategic, tactical, and operational aspects within Quality Assurance.

As a Subject Matter Expert, you will support site validation activities, reviewing and approving quality documentation for these activities.

Key responsibilities include reviewing and auditing complex documents, such as batch records, GMP protocols, and process and method validations, in compliance with QMS, policies, and procedures.

You will also observe manufacturing activities to support the implementation of best practices and improvements, including the transfer of site knowledge to new facility startup activities.

Additionally, you will manage QMS, author, review, and approve SOPs and Policies for the new facility, prepare routine updates and project status reports of Quality Assurance activities, and provide oversight and input to Trend Review Reporting and Lifecycle Review activities.

Finally, you will ensure that documentation is maintained in accordance with internal procedures and regulatory requirements, and support, prepare, and provide Quality training with cross-functional teams as assigned.

Actalent is an equal opportunity employer and values diversity, equity, and inclusion in the workplace.



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