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QA Operations Specialist I

Vaxess Technologies · Woburn, MA · On-site

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About Vaxess Technologies

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1. Terrestrial. Backed by Ulu Ventures.

About the role

Provide day-to-day QA oversight of GMP manufacturing, packaging, QC testing, material handling, equipment, and facility activities. Perform on-the-floor Quality support, including line clearance, material and label verification, documentation review, and resolution of real-time GMP issues. Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Strong attention to detail with the ability to review technical records and identify missing, inaccurate, or inconsistent information required
  • Bachelor’s degree in biology, chemistry, biochemistry, engineering, pharmaceutical sciences, or a related scientific or technical discipline preferred
  • 0-2+ years of experience in Quality Assurance, Quality Control, manufacturing, laboratory operations, engineering, or another regulated environment
  • Basic knowledge of current Good Manufacturing Practices, Good Documentation Practices, data integrity principles, and applicable requirements under 21 CFR Parts 4, 210, 211, and 820
  • Familiarity with analytical testing, laboratory documentation, specifications, analytical data review, and test method qualification or validation principles, including ICH Q2(R2), is preferred
  • Experience in pharmaceutical, biotechnology, medical device, or combination product operations is preferred
More about this role

About Terrestrial Bio, Inc.

Terrestrial is transforming the delivery of next-generation therapies, starting with GLP-1.

Terrestrial's proprietary Tacterra™ microarray patch (MAP) and applicator platform consists of a patch resembling an adhesive bandage, which is applied with a preloaded applicator and removed after a few minutes. Once applied, each patch delivers bioactive tips into the skin, which dissolve quickly into the body, rapidly releasing their therapeutic payload. Designed for self-administration, the temperature-stable Tacterra™ platform enables precise, controlled delivery of a wide range of therapeutics without medical sharps or refrigeration.

Terrestrial has generated strong clinical and in-vivo proof of concept across multiple molecules. For more information, visit www.terrestrialbio.com .

The Quality Operations Specialist I will provide hands-on QA support for day-to-day GMP operations across manufacturing, packaging, QC testing, materials, equipment, and facilities. This role offers the opportunity to build broad Quality experience in a fast-paced combination product environment while helping ensure activities are performed accurately, compliantly, and with...

Read the full posting on Vaxess Technologies's site ↗

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