QA/QC Associate

about 3 years ago
Full time role
Nutley, NJ, US... more
Nutley, NJ, US... more

Job Description

Here at Modern Meadow we are harnessing the power of design, biology, and engineering to produce biofabricated materials. As we continue to grow, we are seeking to hire a QA/QC Associate for our Analytics team. The QA/QC Associate position will support development, implementation and operation of the quality control system.  They will help improve efforts in order to drive sustainable growth at MM and conforming to ISO 9001.  The QA/QC Associate will be responsible for supporting QA/QC for the Materials team, DSP and Analytics.

Responsibilities:

  • Sample Handling
    • Tracking of DSP batches and the various formulations that produce testing results. Assist LIMS administrator in creating the testing parameters in LIMS as needed.
    • It will also be the responsibility of the QA/QC Associate to coordinate BL1 and partner specific sample testing to generate results and help determine specifications.
    • Initiate and implement any SOP’s related to sample handling and proper storage conditions.
    • Support coordinating any external testing and samples for bioburden as needed.
    • Facilitate the submitting and receiving of samples for analytics. This includes the physical storage of samples in the -80C and disposing as necessary. 
    • Improving any sample handling/coordination work-flows and training necessary personnel as needed.
    • Coordinating Personal Care Projects and release/reporting of results.
    • CMO sample submission, which includes shipping samples, tracking reported results, entering results into LIMS.
  • Testing and Data Review
    • Monitor Control Charts for assays and control processes.
    • Assist in establishing a work-flow for testing and reviewing samples, reporting results and correlating data back to DSP batches.
    • Assist in releasing material based on defined specifications.
  • Stability and Raw Material Testing
    • Assess the need for testing and release of raw materials and all that it entails.
    • Tracking of raw materials and components that go into our final formulations.
    • Determine what studies are needed to assess final formulation.
    • Initiate studies as needed to research times and temperatures of final DSP products and final materials.
  • Documentation
    • Train and help roll out QT9 to teams as needed.
    • Writing SOP’s needed for the Quality group.
    • Assist in qualification protocols and writing reports for qualified assays.
    • Determine the needs of the teams and what equipment/instruments need SOP’s. Assist in generating SOP’s as per the Modern Meadow Quality format as well as the review process.

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