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Astrix Technology GMP QA Associate II in Tewksbury, Massachusetts

Seeking a GMP Quality Assurance Associate for our client - the world’s leading producer of stable isotopes and stable isotope-labeled compounds.

In this direct hire role, you will be responsible for upholding compliance and the maintenance of the cGMP/ISO Quality System.

If you have a bachelor's degree within a chemistry or science concentration and experience in GMP/ISO settings, apply today!

Responsibilities:

  • Raw material review and release

  • Perform room/line clearances

  • Review of batch records

  • Revision and creation of documents, including SOP's and forms

  • Label review and final inspection

  • Create batch records, logbooks and controlled forms

  • Perform GMP form reconciliation

  • Assist with initiation, tracking and final distribution of approved documents

  • Perform any related work as required, based upon experience and training

Requirements:

  • BA/BS within a Chemistry or Science concentration preferred.

  • Minimum of 2-5 years of experience in a GMP/ISO setting.

  • Knowledge and/or experience in ISO 17025, ISO 13485, GMP and ICH Q7A is a plus.

Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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