Sr. Associate, Quality Control Microbiology

Employer
Moderna
Location
Massachusetts
Salary
Competitive
Posted
May 12 2017
Organization Type
Biotech
Sr. Associate, Quality Control Microbiology

Position Summary

Reporting to the Director of Quality Control, the Quality Control Microbiology Senior Associate will support the environmental monitoring program for the GMP manufacturing areas, including data trend analysis and conducting investigations.  Also, he/she will assist in the implementation of in-house microbiological testing capabilities in accordance with cGMP requirements and perform testing as required. The individual will act as interdepartmental liaison to various groups including Manufacturing, Quality Assurance, and Development in support of products manufactured at Moderna's manufacturing facility and affiliated contract organizations. This position will start in Cambridge, MA and transition to Norwood, MA.

Responsibilities

  • Supports the environmental monitoring and water sampling programs for the GMP manufacturing areas
  • Implements in-house microbiological testing capabilities in the QC laboratory, including bioburden, endotoxin, sterility, microbial identifications, and water testing as required
  • Conducts validation studies, assay qualifications and special projects as assigned
  • Performs routine testing in support of manufacturing processes
  • Authors quality systems records such as deviations, change controls, CAPAs
  • Troubleshoots assay methods and equipment
  • Supports investigations for Alert/Action excursions, OOS and other non-conforming results; may assist with investigations related to CMO/contract laboratory activities
  • Performs data trending and analysis
  • Trains other laboratory staff on method execution

Qualifications

  • Bachelor's degree in a relevant scientific discipline with a minimum of 4-8 years in a cGMP laboratory with focus in microbiology
  • Working knowledge of USP/EP compendia testing requirements,  cleanroom environments and aseptic technique
  • Experience with compendia test methods (e.g. bioburden, endotoxin) , environmental monitoring and water testing
  • Demonstrated knowledge of method qualifications/validations
  • Strong written and oral communication skills, including technical writing
  • Strong organizational skills, the ability to prioritize work and manage multiple tasks independently
  • Experience in supporting/conducting environmental monitoring excursion investigations
  • Working knowledge of LIMS or environmental monitoring data management systems preferred
  • Experience with rapid microbiological methods preferred

#LI-JA1

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.