• , US

Company:  Confidential

Job Title: Sr. Specialist/Mgr., CMC QA

Job Number: 79109

Location: , US

Job Description

A company is looking for a Senior Specialist/Manager in CMC Quality Assurance. Responsibilities include supporting Quality for CMC Operations at the company’s manufacturing facility and external partners, engaging with the Quality Control (QC) lab, reviewing production data, managing deviations, overseeing batch release and disposition, and driving related activities such as risk management and reviewing/approving CMC SOPs.


* Review and approve clinical batch records, testing, and deviations; perform dispositions. * Provide QA oversight for testing and environmental monitoring. * Review stability activities. * Approve shipping and temperature excursion actions. * Offer on-the-floor QA support as required. * Ensure documentation meets standards. * Review and approve SOPs and specs. * Draft and approve QA SOPs as needed.

Required Skills

* BA/BS with 6-10 years in Quality Assurance in a GMP environment. * Strong knowledge of GMP regulations and quality systems. * Ability to support risk-based Quality Management Systems. * Collaborative approach to ensure compliance and adherence. * Motivated, flexible, with excellent organizational and communication skills. * Preferred experience in cell and gene therapy products and QC analytical methods. * Able to work independently and in multi-disciplinary teams. * Onsite work required at Cambridge facility. * Experienced in managing relationships with internal departments and external vendors in a collaborative manner.

Application Deadline: 2024-07-08


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