Specialist, Quality Control

Moderna • Norwood, MA

6d • $74,000 - $118,400 • Onsite

About The Position

Moderna is seeking a Quality Control Chemistry Specialist based at their Norwood, MA site. The individual in this role will focus on Release, Stability and In Process data review and reporting for clinical and commercial products. This role may support special projects as needed.

Requirements

• Minimum education required: Bachelor’s degree in a relevant scientific discipline, preferred in Analytical Chemistry, or Chemistry
• Minimum experience required: 5 years in a laboratory setting with focus in analytical chemistry
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations (specify GMP.GLP, GCP, GDP or other applicable standards)

Responsibilities

• Perform routine QC analytical chemistry testing including HPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, etc.
• Support execution of method acquisition, qualification, re-qualification protocols
• Supports Troubleshooting of methods and equipment
• Perform data entry and supports trending and analysis
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Supports authoring and revision of equipment, method and other laboratory procedures and reports
• LIMS sample result entry, execution of electronic assay forms
• Perform STAT testing in support to manufacturing process testing as needed, may require shift flexibility
• Stability program support
• Complete and maintain cGMP documentation for work performed.
• Support authoring quality systems records such as deviations, change controls, CAPAs
• Establish and maintain a safety, laboratory working environment
• Follow all relevant GxP regulations guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operation procedures (SOPs) and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

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