Specialist, Quality Control, Equipment

Initial Therapeutics, Inc.

Norwood (MA)

On-site

USD 74,000 - 118,000

Full time

5 days ago
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Benefits offered by this job

Competitive healthcare
Voluntary benefit programs
Well-being resources
Generous paid time off
Bonus potential

Job summary

Moderna in Norwood, MA is seeking a QC Equipment Specialist to manage the equipment lifecycle, coordinate preventive maintenance, and support investigations. The role ensures cGMP compliance and data integrity while working with Facilities, Metrology, Engineering, and Digital teams on-site Monday through Friday.

The successful candidate will have 3–5 years in a GMP-regulated lab, a BS in a scientific field, and hands-on experience with QC equipment, calibration, and CMMS documentation.

Qualifications

  • 3–5 years of experience in a GMP-regulated pharmaceutical/biotech lab
  • Working knowledge of cGMP and Data Integrity (ALCOA+) principles
  • Experience supporting laboratory equipment or quality systems is preferred
  • Strong communication and cross-functional collaboration skills

Responsibilities

  • Support lifecycle management of QC laboratory equipment (installation, qualification, maintenance, calibration, relocation, retirement)
  • Coordinate preventive maintenance, calibration, qualification, and repair with vendors and internal teams
  • Troubleshoot equipment issues and support investigations related to equipment failures
  • Maintain documentation, CMMS records, and equipment-related SOPs and training materials
  • Train QC personnel on equipment operation and routine maintenance
  • Assist with equipment inventory and asset tracking
  • Participate in cross-functional meetings to improve equipment reliability and compliance

Skills

GMP compliance
Cross-functional teamwork
Problem solving
Organizational skills

Education

Bachelor's degree in a scientific discipline

Tools

CMMS
UHPLC systems knowledge

Job description

The Role

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.

Here’s What You’ll Do
  • 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.
Here’s What You’ll Need (Basic Qualifications)
  • Education: B.S. or B.A. in a relevant scientific discipline.
  • Experience: 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.
Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

  • 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

The salary range for this role is $74,000.00 - $118,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow.

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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