Quality Assurance Specialist

  • Indigo
  • Boston, MA
  • Oct 28, 2020

Job Description

Indigo is a company dedicated to harnessing nature to help farmers sustainably feed the planet. With a vision of creating a world where farming is an economically desirable and accessible profession, Indigo works alongside its growers to apply natural approaches, grow healthy food for all, and conserve resources for future generations. The company is headquartered in Boston, MA, with commercial and customer service based in Memphis, TN. www.indigoag.com

The role of the Specialist, Quality Assurance is to ensure that Indigo seed applied microbial products meet established quality standards and expectations by performing microbial analytical procedures to characterize in-process and commercial microbial samples.  Driving process improvement is also central to this role.

Responsibilities:

  • Follow established QC processes and protocols to determine concentration and purity of samples.
  • Perform QC release testing for all product release samples.
  • Conduct stability analysis on concept and final product formulations and assess physical attributes of samples, including viscosity, density and moisture.
  • Record and interpret QC data, using Excel, and report results to QA manager for issuance of Certificate of Analyses.
  • Lead QC monthly data review meetings for stability program with key stakeholders.
  • Maintain supplier relationships with external CMO partners, receive all incoming commercial products for QC analysis.
  • Perform lot disposition activities in QMS System (Oracle)
  • Serve as system administrator in QMS system for QA, serve as review/approver for all Quality related documents such as NCR’s, Investigations, CAPA’s etc.
  • Perform root cause analysis for any non-conformances related to the QA department.
  • Support method validation and tech transfer activities for commercial and pre-commercial products.
  • Coordinate and analyze on-seed stability for treated seed samples
  • Create and maintain cryopreserved cell banks of microbes for distribution to CMO’s.
  • Maintain QA Document Library, assign and maintain training records for all R&D employees via SOPTracker.
  • Occasionally isolate DNA and run PCR on microbial samples
  • Ensure analytic equipment is in good operating order through calibration, troubleshooting, preventive maintenance and related record keeping
  • Execute on contamination preventive initiatives, using 5S methodology

Competencies:

  • Strong attention to detail and accuracy. Organized and methodical
  • Solution oriented thinking and execution
  • Aptitude for mechanical troubleshooting and continuous improvement
  • Good written and verbal communication and presentation skills
  • Team-oriented style and strong work ethic. Works well in a fast-paced environment.
  • Has a track record of delivering on ambitious goals
  • Passion for agriculture and sustainable solutions

Qualifications:

  • Bachelor’s degree in Biology, Biotechnology, or Microbiology with 3-5 years of lab experience or master’s degree with Assay focus.
  • Strong microbiology and associated microbial testing methodologies background, with applied experience in CFU plating, physical attribute testing, and demonstrated proficiency with sterile technique.
  • Experience with data entry, validation and interpretation, with prior use of Excel required.
  • Experience with QMS systems (Oracle) is a plus
  • Experience with Agriculture science work is plus
  • This role is based out of our Boston, MA office

Indigo is committed to living our values, specifically “creating a work environment where everyone feels respected, connected, and has opportunities to learn and grow.” As part of living our values, we strive to create a diverse and inclusive work environment where everyone feels they can be themselves and has an equal opportunity of succeeding.

Organization Type

Company  

Sectors

Food & Agriculture

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