(Contract) Associate I, Quality Control

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
May 07 2019
Ref
R1631
Discipline
Life Sciences, Biology
Organization Type
Biotech
(Contract) Associate I, Quality Control

The Role:

Moderna is seeking a 2nd shift Quality Control Sample Management Associate I based at their Norwood, MA site. The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, Analytical Development and Drug Product Development labs. Also, this individual may support special projects as assigned. This anticipated time frame for this assignment is 6 months.

Here's What You'll Do:
  • Sample coordination including cross functional collaboration with internal and external labs
  • Receipt, processing, distribution and shipment of the following sample types:
    • In-Process, DS, Formulation and DP
    • Equipment cleaning
    • Stability
    • Raw Materials
  • Coordinating domestic and international sample shipments
  • Communication with external Contract Test Labs (CTLs)
  • Inspect product and raw material retention samples
  • LIMS (LabVantage) sample logging and result entry
  • AQL visual inspection of drug product
  • Raw material component inspection and release
  • May perform NaOH plate reader based assay in support of manufacturing process stat testing as needed
  • Stability program support
  • Controlled temperature unit management, maintenance and troubleshooting
  • Clean room gowning
  • Managing/stocking of QC lab supplies
  • Write/revise SOPs, protocols and reports
  • Complete and maintain cGMP documentation for work performed
  • Participate in authoring quality systems records such as deviations, change controls, CAPAs
  • Support non-conformance investigations
  • Establish and maintain a safe laboratory working environment


Here's What You'll Bring to the Table:
  • Minimum experience/education required: 5+ years in a cGMP laboratory setting or Bachelor's degree in a relevant scientific discipline with 1+ years in a cGMP laboratory setting preferred
  • Minimum knowledge required: cGMPs
  • Minimum skills required:
    • Technical writing
    • Proficiency with Microsoft Office Programs
    • Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, EDMS, CMMS, LMS)
  • Strong written and oral communication skills as well as organizational skills
  • Knowledge of industry standards and guidelines
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science's list of top biopharma industry employers for the past four years. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-DNI

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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.

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