This role provides technical and scientific leadership to a manufacturing Quality Assurance team. Technical review, validation, and approval of all process changes and improvements. Responsible for technical review and approval of all deviations and non-conformances and developing experimental plans for the troubleshooting and root cause investigation into all non-conforming product – this includes the review of data and implementation of corrective and preventive actions.

This role will additionally provide technical support to the manufacturing team for the commercialization of new assays from the R&D team.


Essential functions of the job are listed below. Other responsibilities may also be assigned. Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location. Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

  • Develop experimental plans for non-conformance investigations, deviations and process validations
  • Review of all quality control data as well as process validations, deviations, and non-conformance investigations and provide recommendations
  • Provide technical review of documentation as part of DCRA process
  • Provide training and supervision to quality laboratory staff
  • Carry out troubleshooting and process validation experiments
  • Assist with quality processes- including audits- as needed
  • Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates.
  • Actively supports and ensures all lab personnel live-by and participate in the Safety Program.
  • Carries out all responsibilities in an honest, ethical and professional manner



In accordance with applicable policies/procedures and Federal/State laws, may perform the following supervisory responsibilities: Interviewing, hiring orienting and training employees, planning, assigning/directing work, coaching and appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; enforcing all safety rules and ensuring safe work procedures.



The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position. Please note that the minimum qualifications may vary based upon the department size and/or geographic location.


  • Advanced degree in Molecular Biology, Microbiology or a related field required. Will consider BS/MS candidates with appropriate level of skill.
  • Minimum of 5 years of experience in Molecular Diagnostics, Food Pathogens, Oligonucleotide(s) Quality Assurance Laboratory:
    • Knowledge of molecular diagnostic, microbiologic or rapid-test biochemistry in a manufacturing setting
      • Polymerase Chain Reaction (PCR)
      • Southern Blotting
      • Enzyme activity assays
      • Bacterial/fungal culture
      • Assay development
      • Biochemical Identification of Microorganisms
      • Chromogenic Media and Rapid Test Development
      • Expert knowledge of media, buffers, solution and reagent chemistry
    • Designing experimental protocols
    • Troubleshooting assay failures
    • Working in an ISO 9001-compliant manufacturing environment
    • Carrying out non-conformance root cause investigations, implementing corrective actions, and managing change control processes
  • Three (3) years (or more) of direct supervisory experience
  • Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required


  • The ability to recognize, attract, retain and ‘grow’ talented scientists
  • Excellent verbal and written communication
  • Must be able to use discretion and independent judgment
  • Must be able to work in a team environment
  • Must be able to pay close attention to details
  • Must be able to adapt and flex to a changing environment
  • Must be able to lift/carry 20 pounds
  • Understanding and application of statistical tools for data analysis; experience of MiniTab Software or equivalent is a benefit.
  • Interpretation and presentation of results of data analysis



  • Will occasionally be required to travel
  • May occasionally work evenings and/or weekends


  • Please upload a PDF of your resume here