1 Associate I, Quality Assurance (Contract) Job in Waltham, MA
ElevateBio is Hiring an Associate I, Quality Assurance (Contract) Near Waltham, MA
The RoleElevateBio is looking for an Associate I, QA Operations to join their growing Quality Group at our BaseCamp facility in Waltham, MA. In this role, the Associate I 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.
Here’s What You’ll Do
- Conduct thorough reviews of batch records, ensuring adherence to established procedures, specifications, and regulatory requirements.
- Verify that validated processes are consistently followed on the manufacturing floor.
- Document activities clearly and concisely using strong technical writing skills.
- Perform review of work orders and OOT reports for equipment/ utilities.
- Perform visual inspection of final product.
- Foster clear communication with colleagues across departments, both verbally and in writing.
- Maintain a strong working knowledge of our Quality Management System (QMS) and relevant GxP regulations.
- 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.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Provide on-the-floor QA oversight and support in the GMP cleanroom to ensure Compliance to GMP regulations throughout the manufacturing areas.
- Holds a Bachelor's degree in a relevant scientific field (or) an Associate's degree with a minimum of 2 years of experience in a QA/QC laboratory or manufacturing setting.
- Possesses a keen eye for detail and a commitment to upholding the highest quality standards.
- Demonstrates strong problem-solving skills and the ability to think critically.
- Has a passion for learning and staying up-to-date on regulatory requirements.
- Thrives in a fast-paced, collaborative environment.
- Experience working in a GxP manufacturing environment.
- Familiarity with specific GxP regulations (e.g., cGMP, ICH guidelines).
- Prior experience with deviation and non-conformance management.
We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.
Our MissionTo power the creation of life-transforming cell and gene therapies, at a speed the world deserves.
Our VisionWe seek to be the world’s most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.
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.
Job Summary
Contractor
Scientific Services
$72k-90k (estimate)
07/03/2024
07/31/2024
elevate.bio
KENDALL SQUARE, MA
200 - 500
2018
MORANAJOVA EMBIRICOS
$10M - $50M
Scientific Services
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