QC Stability Associate II — GMP Quality Control

Moderna; Norwood (MA); On-site; USD 63,000 - 101,000; Full time

Benefits offered by this job

Competitive healthcare

Well‑being resources

Family planning benefits

Generous paid time off

Savings and investments

Location‑specific perks

Job summary

Moderna is seeking a Quality Control Stability Associate II to join our QC Stability team in Norwood, MA. You will support routine GMP stability programs across clinical and commercial efforts, ensuring procedures and policies meet GxP and GMP requirements.

Responsibilities include stability sample handling, scheduling, equipment validation checks, inventory management, and adherence to data integrity and safety standards. This onsite role emphasizes teamwork and regulatory readiness.

Qualifications

• Bachelor’s degree in a relevant scientific discipline.
• 2–3 years in a GMP QC laboratory setting with a focus on Stability.
• Knowledge of cGMPs and general laboratory safety.
• Pipetting proficiency; familiarity with electronic databases (LIMS, SAP, eQMS, CMMS).
• Strong written and oral communication and organizational skills.

Responsibilities

• Perform day-to-day routine stability program operations, including sample pulls and shipments.
• Create and maintain stability scheduling to meet timelines.
• Ensure proper operation of stability temperature units and cold rooms.
• Respond to out-of-range alerts and escalate as needed.
• Handle stability study materials per procedures and protocols.
• Stock QC lab supplies and consumables; maintain safety compliance.
• Follow SOPs, data integrity practices, and GMP regulations.
• Complete required trainings and participate in audits/inspections as needed.

Skills

Pipetting

Microsoft Office

LIMS

SAP

eQMS

CMMS

Strong communication

Organizational skills

Education

Bachelor's degree

Tools

LIMS

SAP

eQMS

CMMS

Job description

Moderna is seeking a Quality Control Stability Associate II to join our QC Stability team in Norwood, MA. You will support routine GMP stability programs across clinical and commercial efforts, ensuring procedures and policies meet GxP and GMP requirements.

Responsibilities include stability sample handling, scheduling, equipment validation checks, inventory management, and adherence to data integrity and safety standards. This onsite role emphasizes teamwork and regulatory readiness.