The Role:

ElevateBio is looking for an Associate II, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Associate 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 defined assignments, knowledgeable of cGMP best practices, applies knowledge to troubleshoot using source documentation, and proactively seeks resources to build on own experience. Schedule will be eventually shifting to four 10 hour shifts, either Sun-Wed or Wed-Sat. 

Here’s What You’ll Do:

• 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.
• Ensure timely resolution and escalation of issues within the operational areas.
• Ensure all product-related Deviations are initiated, investigated, and resolved.
• Ownership and investigation minor deviations.
• Perform Batch Record and Logbook review.
• Perform visual inspection of final product.
• Identify compliance risks and escalate the issues to appropriate levels of management for resolution.

Requirements:

• BA/BS degree with a minimum of 2 - 3 years of experience in a pharmaceutical, biotechnology or biologics operation with 1 year of direct QA experience.
• Experience in Viral Vectors, Cellular and Gene Therapy Products is desired.
• Working knowledge and ability to apply GMPs.
• Strong teamwork and collaborative skills.
• Experience with manufacturing investigations, deviations, and CAPA.
• Strong knowledge with aseptic manufacturing processes is preferred.
• Experience in electronic Enterprise Management systems, Quality Management Systems, Document Management Systems.