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Specialist II, QA Operations (Rotating 12 Hour Shifts) (Multiple Openings)

ElevateBio

ElevateBio

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See open jobs at ElevateBio.See open jobs similar to "Specialist II, QA Operations (Rotating 12 Hour Shifts) (Multiple Openings)" Greatness.bio.
Operations, Quality Assurance
Waltham, MA, USA
Posted on Tuesday, July 16, 2024

ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.

The Role:

We're seeking a passionate and detail-oriented Specialist II, QA Operations to join our expanding Quality team at our BaseCamp facility in Waltham, MA.

Here’s What You’ll Do:

  • Ensure top-notch quality in cell and gene therapy manufacturing by providing oversight on the production floor.
  • Partner with operations to guarantee timely completion and accuracy of batch records and related documents.
  • Conduct inspections, review processes, and identify potential compliance risks.
  • Uphold cGMP regulations throughout manufacturing by performing quality walk-throughs and observations.
  • Manage critical tasks like receiving apheresis material, issuing production documents, and inspecting final products.
  • Champion quality by initiating, investigating, and resolving deviations and CAPAs (Corrective and Preventive Actions).
  • Own and manage quality records like minor/major deviations, CAPAs, change controls, batch records, and logbooks.
  • Collaborate with the team to effectively resolve operational issues and ensure timely closure of quality records.

Requirements:

  • Bachelor's degree (BA/BS) with a minimum of 5 years' experience in a pharmaceutical, biotech, or biologics environment. (Experience with viral vectors, cellular and gene therapy products a plus!)
  • In-depth knowledge and proven ability to apply cGMP regulations.
  • Strong teamwork and communication skills to foster a collaborative environment.
  • Prior experience with investigations, deviations, CAPAs, and change control practices.
  • Familiarity with aseptic manufacturing processes (preferred).
  • Experience working with electronic systems like Enterprise Management Systems (EMSs), Quality Management Systems (QMS), and Document Management Systems (DMS).

Why Join ElevateBio?

ElevateBio is a technology-driven company built to power transformative genetic medicines today and for many decades to come. The Company commercializes its enabling technologies, manufacturing capabilities, and industry-leading expertise through partnerships to accelerate development across a breadth of therapeutic approaches and modalities. The ElevateBio ecosystem combines multiple R&D technology platforms – including Life Edit, a next-generation, full-spectrum gene editing platform; comprehensive cell engineering technologies; and an expanded viral and non-viral therapeutic delivery platform – with BaseCamp®, its end-to-end genetic medicine cGMP manufacturing and process development business, to accelerate the discovery and development of advanced therapeutics.

We aim to be the dominant engine inside the world’s greatest scientific advancements harnessing human cells and genes to alter disease.

Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.

Our Vision:
We 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.

This job is no longer accepting applications

See open jobs at ElevateBio.See open jobs similar to "Specialist II, QA Operations (Rotating 12 Hour Shifts) (Multiple Openings)" Greatness.bio.
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