Sr. Specialist, Quality Control Raw Materials

Moderna • Norwood, MA

21h • $74,000 - $118,400 • Onsite

About The Position

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).

Requirements

• BS in a relevant scientific discipline.
• 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.

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, 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.

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: Senior