Specialist, Quality Control, Equipment

ModernaTX • Norwood, MA

3d • Onsite

About The Position

Moderna is seeking a Candidate based at their Norwood, MA site. The individual in this role will focus on support and upkeep of the QC equipment lifecycle along with supporting training. The individual will coordinate across multi-discipline teams to meet business objectives and may also support investigations for Quality Events. The QC Equipment Specialist will report to the QC Equipment Sr. Manager and will be on-site M-F.

Requirements

• B.S. or B.A. in a relevant scientific discipline.
• 3 to 5 years of experience in a GMP-regulated pharmaceutical, biotechnology, or related laboratory environment.
• Working knowledge of cGMP regulations, Good Documentation Practices, and Data Integrity (ALCOA+) principles.
• Experience supporting laboratory equipment, instrumentation, or quality systems preferred.
• Strong organizational, communication, and problem-solving skills with the ability to work effectively in a cross-functional team.

Responsibilities

• Support the lifecycle management of QC laboratory equipment, including installation, qualification, maintenance, calibration, relocation, retirement, and documentation activities.
• Troubleshoot equipment issues and support investigations related to equipment failures, system deficiencies, deviations, and laboratory operations.
• Perform basic, non-invasive maintenance and troubleshooting on laboratory instrumentation (e.g., UHPLC systems), including replacement of consumable components and coordination of vendor support as needed.
• Serve as a primary QC point of contact for equipment-related inquiries and coordinate with vendors, Facilities, Metrology, Engineering, and Digital teams to resolve issues.
• Coordinate preventive maintenance, calibration, qualification, and repair activities to minimize equipment downtime and ensure compliance with site schedules.
• Support CTU alarm response activities and coordinate equipment recalibration and requalification following alarm events or out-of-tolerance conditions.
• Review preventive maintenance documentation, calibration certificates, CMMS records, and equipment documentation to ensure accuracy, completeness, and compliance.
• Submit and manage asset induction requests, work orders, and administrative requests within the CMMS to support accurate equipment lifecycle management.
• Assist with equipment inventory management, including tracking assets, coordinating equipment movement, and maintaining laboratory equipment records.
• Support equipment-related quality systems activities, including deviations, change controls, CAPAs, investigations, and periodic reviews.
• Author, revise, and maintain equipment-related SOPs, work instructions, forms, and training documentation.
• Train QC personnel on equipment operation, routine maintenance, and applicable procedures.
• Perform data entry, trending, reporting, and documentation using electronic laboratory and quality systems while maintaining cGMP and Data Integrity (ALCOA+) compliance.
• Order equipment consumables and laboratory supplies and maintain appropriate inventory levels.
• Participate in cross-functional meetings and continuous improvement initiatives to improve equipment reliability, compliance, and operational efficiency.
• Support method implementation, troubleshooting, and optimization activities as they relate to laboratory equipment.

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