ElevateBio Specialist I/II, QA Operations in Waltham, Massachusetts
Title: Specialist I/II, QA Operations
Location: Waltham, MA
Reports to: Associate Director, QA Operations
The Role:ElevateBio is looking for a Specialist, QA Operations to join their growing Quality group. In this role, the Quality Specialist will be responsible for providing appropriate oversight to ensure cGMP compliance of clinical cell therapy products produced by ElevateBio. The Specialist provides a link between operations and the various quality systems. The primary responsibility is to directly support Operations through real-time, on-line batch record QA review and approval.
Here?s What You?ll Do:
Provide on-the-floor QA oversight in GMP cleanroom and laboratory environments and support to ensure compliance to GMP regulations throughout those 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.
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 lot closure and disposition activities.
Ensure approval and timely delivery of final product.
Oversee the shipping process and perform final product shipment authorization.
Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
BA/BS degree with 3-5 years of experience in n a pharmaceutical, biotechnology or biologics operation.
Experience in Viral Vectors, Cellular & Gene Therapy Products.
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.
Strong knowledge with aseptic manufacturing processes
Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.
Why join ElevateBio?
ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities.
At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.
Our Vision:Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies
ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person?s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.