Associate II, Quality Control

ModernaTX • Norwood, MA

9d • Onsite

About The Position

Moderna is seeking a Quality Control Chemistry Associate II based at their Norwood, MA site. The individual in this role will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed. This role will be working on the 2nd shift Sunday through Thursday.

Requirements

• BA/BS in relevant scientific discipline
• 2 years of Laboratory experience.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations.

Responsibilities

• Performs routine analytical chemistry testing including HPLC, UPLC, GC, UV, Particle Analysis and Dynamic Light Scattering, KF, etc.
• Supports special projects as assigned.
• May assist with Troubleshoots assay methods and equipment.
• Performs data entry and supports trending.
• Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
• Supports authoring of SOPs, protocols and reports.
• LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
• Perform HPLC (AEX) and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
• Stability program support.
• Support more junior staff with data review, training, and troubleshooting.
• 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 investigations, deviations, change controls, CAPAs
• Establish and maintain a safe 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 operating 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