Specialist, Quality Control

ModernaTX, Inc.; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Family planning benefits

Generous paid time off

Job summary

Moderna, Inc. is seeking a Specialist, Quality Control to help drive digital transformation of QC processes and support AI-driven initiatives and enterprise Lab Systems.

You will collaborate with QC and Digital teams to configure and deploy digital systems in QC as needed. The role includes day-to-day support for QC laboratory systems (LIMS, Chromeleon), system administration, and primary Tier 1 support, plus involvement in validation, change controls, and training to ensure GMP-compliant

Qualifications

• BS degree in sciences or related field
• 3-5 years in biotech/biopharma, preferably QC, Digital, or Automation
• Familiarity with AI applications and data analysis in GMP environment
• Experience with laboratory informatics systems (LIMS, Chromatography Data Systems) a plus
• Strong problem-solving and communication skills; able to work cross-functionally
• Experience in biopharmaceutical & GMP

Responsibilities

• Provide day-to-day support for QC lab systems (LIMS, Chromeleon) and ensure performance
• Perform routine system administration: user access, config updates, maintenance, upgrades coordination
• Primary Tier 1 support for lab computer systems, document resolutions, escalate complex issues
• Support implementation, testing, deployment of system enhancements and updates
• Maintain SOPs, work instructions, and training materials
• Support quality system activities: deviations, change controls, CAPAs, validation docs
• Train QC personnel on software and best practices
• Identify process improvements to simplify workflows and improve usability
• Support AI-powered and digital solutions for QC data review, trending, reporting, automation
• Collaborate with QC, Digital, Automation to translate business needs into AI solutions
• Ensure AI/digital tools comply with GMP and ALCOA+
• Monitor performance/adoption of tools and provide training on new tech
• Coordinate with IT, Regulatory to align with corporate AI strategies
• Follow GMP, GxP guidelines and internal policies
• Execute tasks per SOPs and Good Documentation/Data Integrity for audits

Skills

Problem solving

Communication

Cross-functional collaboration

AI familiarity

GMP knowledge

Education

BS in Sciences or relevant field

Tools

LIMS

Chromeleon

Job description

The Role

The Specialist, Quality Control will serve as a key contributor to the digital transformation of QC processes, supporting AI-driven initiatives and support of enterprise Lab Systems. The Specialist will collaborate with QC and Digital teams to meet business objectives and assist in the configuration and deployment of Digital systems in QC as needed.

Here’s What You’ll Do

• Provide day-to-day support for QC laboratory systems, including LIMS, Chromeleon, and other enterprise laboratory applications, ensuring reliable system performance and timely issue resolution.
• Perform routine system administration activities, including user access management, configuration updates, software maintenance, and coordination of system installations and upgrades with Digital teams.
• Serve as the primary Tier 1 support resource for laboratory computer systems, troubleshooting system issues, documenting resolutions, and escalating complex issues as appropriate.
• Support implementation, testing, and deployment of system enhancements, software updates, and new functionality to meet QC business needs.
• Author, revise, and maintain equipment, software, business administration, and system lifecycle documentation, including SOPs, work instructions, and training materials.
• Support quality system activities related to laboratory software, including deviations, change controls, CAPAs, periodic reviews, and validation documentation, ensuring compliance with GMP and Data Integrity (ALCOA+) requirements.
• Train and support QC personnel on laboratory software and system functionality, providing guidance on system use and best practices.
• Participate in continuous improvement initiatives by identifying opportunities to simplify processes, improve system utilization, and enhance the user experience.
• Support the development, implementation, and continuous improvement of AI-powered and digital solutions that enhance Quality Control laboratory operations, including data review, trending, reporting, and workflow automation.
• Partner with QC, Digital, and Automation teams to translate business needs into scalable AI-enabled solutions and integrate new technologies into existing QC systems.
• Ensure AI and digital capabilities comply with GMP requirements, Data Integrity (ALCOA+) principles, and applicable regulatory expectations, including supporting validation, change control, and quality documentation.
• Monitor the performance and adoption of AI and digital tools, identify opportunities for optimization, and provide training and guidance to QC personnel on new technologies.
• Collaborate with internal stakeholders, including IT, Digital, and Regulatory teams, to ensure alignment with corporate AI strategies.
• 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.

Here’s What You’ll Need (Basic Qualifications)

• Education: BS in Sciences or relevant scientific field
• Experience: 3-5 years of experience in the biotechnology/biopharmaceutical industry, preferably in a QC, Digital, or Automation role.
• Familiarity with AI applications, data analysis tools, and digital solutions in a GMP environment is preferred.
• Understanding of laboratory informatics systems (e.g., LIMS, Chromatography Data Systems) is a plus.
• Specific Certifications or Training: None
• Strong problem-solving skills and ability to troubleshoot AI-related QC processes.
• Excellent communication skills and ability to work in cross-functional teams.
• Experience in biopharmaceutical & GMP.

Pay & 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
• 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.

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 [e-mail].

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.