Sr. Specialist, Quality Control Raw Materials

Regulatory Jobs; Norwood (MA); On-site; USD 74,000 - 118,000; Full time

Job summary

Moderna is seeking a QC Raw Material professional to perform release and inspection activities for GMP manufacturing. The role emphasizes cGMP documentation, risk assessments, and collaboration with internal and external labs on methods like HPLC and TruScan.

Responsibilities include review of supplier documentation, audit support, lab investigations, and maintaining a safe, compliant lab environment. 100% onsite with standard 5x8 shifts; strong regulatory knowledge is essential.

Qualifications

• Education: BS in a relevant scientific discipline.
• Experience: 6+ years with BS or 8+ years in GMP QC laboratory setting.
• Demonstrated aptitude or ability to learn: Demonstrate strong understanding of GxP.
• Regulations and Problem Solving.

Responsibilities

• Oversight of prioritization and release of raw materials to meet metrics and turnaround times.
• Review of Raw Data, supplier certification and incoming documentation to meet requirements.
• Specification review and approval.
• Support Continuous Improvement of lab operations.
• Project management and execution to deliverables and timelines.
• Audit support during Regulatory and Health Authority Inspections.
• Requesting, sampling, releasing, and shipping of raw materials.
• Sample coordination including cross functional collaboration with internal and external labs.
• Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity, TruScan.
• RM spectroscopy, appearance, and dimensional verification.
• Supporting domestic and international sample shipments.
• Inspect product and raw material retain samples.
• LIMS (LabVantage) sample logging and result entry.
• Raw material and consumable component inspection and release.
• Controlled temperature unit management, maintenance, and troubleshooting.
• Clean room gowning and aseptic techniques.
• Write/revise SOPs, protocols, and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs.
• Lead laboratory investigations and deviations as required.
• Conduct and lead risk assessments.
• QC Management designee for QC inspection label issuance and reconciliation.
• Establish and maintain a safe laboratory working environment.
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
• 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 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.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Skills

GxP understanding

Regulatory knowledge

Project management

Education

BS in a relevant scientific discipline

Tools

HPLC

Bioanalyzer

Osmolality

pH

Conductivity

TruScan

LIMS (LabVantage)

Job description

The Role

The individual in this role will perform QC Raw Material activities in support of GMP Manufacturing and special projects as assigned. This role is 1st shift, Monday to Friday (5 x 8hrs).

Here’s What You’ll Do

• Oversight of prioritization and release of raw materials to meet metrics and turnaround times.
• Review of Raw Data, supplier certification and incoming documentation to meet requirements.
• Specification review and approval.
• Support Continuous Improvement of lab operations.
• Project management and execution to deliverables and timelines.
• Audit support during Regulatory and Health Authority Inspections.
• Requesting, sampling, releasing, and shipping of raw materials.
• Sample coordination including cross functional collaboration with internal and external labs.
• Train and perform testing for methods including HPLC, Bioanalyzer, osmolality, pH, conductivity, TruScan.
• RM spectroscopy, appearance, and dimensional verification.
• Supporting domestic and international sample shipments.
• Inspect product and raw material retain samples.
• LIMS (LabVantage) sample logging and result entry.
• Raw material and consumable component inspection and release.
• Controlled temperature unit management, maintenance, and troubleshooting.
• Clean room gowning and aseptic techniques.
• Write/revise SOPs, protocols, and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs.
• Lead laboratory investigations and deviations as required.
• Conduct and lead risk assessments.
• QC Management designee for QC inspection label issuance and reconciliation.
• Establish and maintain a safe laboratory working environment.
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement.
• 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.
• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here’s What You’ll Bring to the Table (Basic Qualifications)

• Education: BS in a relevant scientific discipline.
• Experience: 6+ years with BS or 8+ experience in GMP QC laboratory setting.
• Demonstrated aptitude or ability to learn: Demonstrate strong understanding of GxP.
• Regulations and Problem Solving.

Our Working Model

As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.

Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

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.

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.

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].

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

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.