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Actalent Quality Associate in Agoura Hills, California

Cell Therapy startup is looking for a quality associate to join their Technical Operations team!! There will be a focus on quality and manufacturing data review in preparation for upcoming FDA submissions. Opportunity to expand your skillset within the QA and regulatory space!

QA or QC experience from a GMP environment is required

cell therapy experience preferred

Description:

In this role, you will have the opportunity to make an impact and play a key role in ensuring data integrity and quality of precision-targeting cellular drug therapies. Seeking a detail-oriented team player with a strong motivation for driving quality work.

Responsibilities:

Ensure data integrity through review of draft regulatory submission documents, reports, electronic laboratory notebooks to ensure accuracy to source documents according to program timelines

Author technical reports to document that data has been verified

Organize document verification workflow and tracking

Work with electronic laboratory notebooks and quality management system to gather and verify data

Coordinate with document authors to reconcile discrepancies and verify updates once made

Work with other functions within Technical Operations on data verification needs

Perform other duties to fulfill department and business needs

Skills:

GMP, Quality Assurance, Cell culture, Quality Control, Batch Record, data integrity, FDA, submissions, regulatory, cell therapy, data analysis

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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