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Quality Engineer - Validation

Company: Cellmig Biolabs
Location: Cambridge
Posted on: January 16, 2022

Job Description:

Job Summary Cellmig Biolab 's world-class research and development team is turning pioneering discoveries into translational medicines for the diagnosis and pharma-therapy of cancer metastasis. We have successfully identified a novel organelle termed cytocapsulae, which allow for a new mechanism of the detection of cancer cell migration. Our goal is to use this finding to create breakthrough biomolecules and diagnostic devices to target tumor metastasis. We are working in advancing our products in clinical validation programs and applications. Cellmig Biolabs is seeking a Quality Engineer - Validation to support the company 's validation activities. The ideal candidate will play a critical role in the validation of our first antibody and successive pipeline projects. This candidate will join an enthusiastic integrated, interdisciplinary team developing powerful new In Vitro Diagnostic (IVD) products used to detect cancer metastasis. If you are passionate about developing groundbreaking technology, participating from product concept to launch and enjoy applying problem solving techniques to complex problems and have excellent interpersonal and leadership skills, then this role could be for you. Duties and Responsibilities This role will require you to apply your technical background to the development of leading-edge medical technology. You must have the ability to work both independently and cross-functionally with the Antibody Development team to assist and provide guidance on design validation activities. Such activities include, but are not limited to:

  • Draft detailed test procedures that assess systems and product against documented requirements.
  • Develop test methods and acceptance criteria for all development testing including verification activities while collaborating with cross functional team members.
  • Identify any necessary equipment and draft and execute any necessary IQ/OQ/PQ activities
  • Conduct statistical analysis of test results.
  • Escalate quality events, as necessary, to management and provide solutions to these events as needed.
  • Other duties and responsibilities as assigned. Goals This position will play a crucial role in taking Cellmig Biolab 's primary candidate to market within predefined company projected timeline.YourMembership. Keywords: Quality Control / Quality Assurance Engineer, Location: Cambridge, MA - 02139

Keywords: Cellmig Biolabs, Cambridge , Quality Engineer - Validation, Engineering , Cambridge, Massachusetts

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