QC Equipment Specialist: Lifecycle & Compliance

Biopharma Careers; Norwood (KY); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Healthcare

Well-being program

Family planning benefits

Generous PTO

Investment options

Job summary

Moderna is seeking a QC Equipment Specialist based in Norwood, MA, to manage the QC equipment lifecycle, support instrument maintenance, and drive cross-functional collaboration across Facilities, Metrology, Engineering, and Digital teams. On-site Monday–Friday, with focus on QA quality systems and cGMP compliance.

The role emphasizes training QC personnel, maintaining documentation, and participating in continuous improvement to ensure reliable equipment performance and data integrity.

Qualifications

• Bachelor degree in a relevant scientific discipline.
• 3–5 years of GMP-regulated lab experience.
• Knowledge of cGMP, GDP, and ALCOA+ Data Integrity principles.
• Experience with lab equipment, instrumentation, or quality systems.
• Strong organizational and cross-functional teamwork skills.

Responsibilities

• Oversee QC equipment lifecycle: installation, qualification, maintenance, calibration, relocation, retirement, and documentation.
• Troubleshoot equipment issues and support investigations related to failures, deviations, and laboratory operations.
• Perform basic non-invasive maintenance on lab instrumentation and coordinate vendor support.
• Act as primary QC contact for equipment inquiries and coordinate with Vendors, Facilities, Metrology, Engineering, and Digital teams.
• Coordinate preventive maintenance, calibration, qualification, and repair activities to minimize downtime.
• Support CTU alarm responses and recalibration after alarms or out-of-tolerance conditions.
• Review PM documentation, calibration certificates, CMMS records for accuracy and completeness.
• Submit asset inductions, work orders, and admin requests in CMMS.
• Assist with equipment inventory management and asset tracking.
• Support quality systems activities: deviations, change controls, CAPAs, investigations, and reviews.
• Author and maintain equipment SOPs, work instructions, forms, and training docs.
• Train QC personnel on equipment operation and maintenance.
• Data entry, trending, and reporting with ALCOA+ compliance.
• Order consumables and maintain inventory.
• Participate in cross-functional meetings and continuous improvement.
• Support method implementation, troubleshooting, and optimization of equipment.

Skills

Cross-functional collaboration

Problem-solving

Strong communication

Organizational skills

GMP knowledge

Education

B.S./B.A. in a scientific discipline

Tools

UHPLC systems

CMMS

Job description

Moderna is seeking a QC Equipment Specialist based in Norwood, MA, to manage the QC equipment lifecycle, support instrument maintenance, and drive cross-functional collaboration across Facilities, Metrology, Engineering, and Digital teams. On-site Monday–Friday, with focus on QA quality systems and cGMP compliance.

The role emphasizes training QC personnel, maintaining documentation, and participating in continuous improvement to ensure reliable equipment performance and data integrity.