Associate II, Quality Control

Moderna • Norwood, MA

10d • $63,200 - $100,900 • Onsite

About The Position

Moderna is seeking an Associate II with cGMP quality control analytical testing experiences. The individual in this role will perform in process, release and stability testing in quality control Chemistry laboratory. This individual may also support special projects as assigned.

Requirements

• BA/BS in Chemistry (preferred) or other relevant scientific discipline
• Working experience: at least two years in quality control laboratory in a pharmaceutical company

Responsibilities

• Work on in-process, release and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH and other regulatory requirements.
• Routinely use analytical equipment including, but not limited to HPLC, UPLC, UV plate reader, particulate matter, particle size analysis with Dynamic Light Scattering, KF, Osmolality, etc.
• Follow current test methods and/or protocols to perform analytical testing.
• Document the testing procedure and results using Assay Performance Worksheets and/or LIMS as per GDP requirements and submit data packets for review
• Maintain compliance to data integrity and cGMP in QC lab in line FDA and ICH guidance.
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.
• May assist with troubleshooting of assay methods and equipment.
• Involved in lab investigations, OOS, OOT, OOE and deviation investigations.
• May Implement CAPAs and perform effectiveness check.
• Complete on job training activities
• Help with inventory management of reference standards, reagents, supplies for testing
• Review/write/revise SOPs, protocols and reports
• Establish and maintain a safe laboratory working environment
• Supports special projects as assigned
• Additional duties as may be assigned

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level