Specialist I, QA Operations
About The Position
ElevateBio is looking for a Specialist I, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Specialist II will be primarily responsible for providing Quality oversight over execution of clinical cell and gene therapy manufacturing for cGMP compliance through on the production floor interactions, review and approval of batch related documents, and events. This individual will engage with other members within operational departments as a Quality partner by providing real-time support in order to achieve on-time closure of quality records. A successful candidate in this position will effectively execute complex assignments, apply knowledge of best practices of cGMP to define solutions, and has subject matter expertise within Quality related functions.
Requirements
- BA/BS degree with a minimum 5 years of experience in a pharmaceutical, biotechnology or biologics operation.
- Working knowledge and ability to apply GMPs.
- Strong teamwork and collaborative skills.
- Experience with manufacturing investigations, deviations, and CAPA.
- Experience with change control practices and strategies.
Nice To Haves
- Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
- Strong knowledge with aseptic manufacturing processes is preferred.
- Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems
Responsibilities
- Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure compliance to GMP regulations throughout the manufacturing areas.
- Perform quality walk-throughs and process observations.
- Perform receipt and disposition of incoming patient apheresis material.
- Perform issuance verification of production documents and labels, to meet production schedule.
- Perform visual inspection of final product.
- Ensure timely resolution and escalation of issues within the operational areas.
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Ensure all product-related Deviations are initiated, investigated, and resolved.
- Ensure that associated CAPAs are initiated and resolved.
- Perform review of quality records including lab investigations, work orders, and change controls.
- Ownership of quality records such as deviations, CAPAs, and change controls.
- Perform Batch Record and Logbook review
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
