Associate II, Quality Control, Sample Management and Chemistry (2nd Shift)

Employer
Moderna
Location
Norwood, MA
Salary
Competitive
Posted
June 26 2019
Ref
R1703
Organization Type
Biotech
Associate II, Quality Control, Sample Management and Chemistry (2nd Shift)

The Role:
Moderna is seeking a 2nd shift Quality Control Sample Management Associate II based at their Norwood, MA site. The individual in this role will primarily perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, Analytical Development and Drug Product Development labs. Also, this individual will support QC Analytical Testing and special projects as directed by management.

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
  • LIMS (LabVantage) sample logging and result entry.
  • Support LIMS improvement and expansion projects, along with other digital infrastructure initiatives.
  • AQL visual inspection of drug product.
  • Performance of STAT Plate Reader and HPLC based assays in support of manufacturing as needed.
  • Performance of QC Chemistry assays, including HPLC and Plate Based assays for product release and stability.
  • Stability program support, including support of study management and sample pulls.
  • 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: Bachelor's degree in a relevant scientific discipline with a minimum of 2 years in a cGMP laboratory setting, or applicable experience in a regulated lab environment.
  • 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.


Here's What We'll Bring to the Table:
  • Daily on-site subsidized cafeteria
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


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-PL1

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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