Senior QC Lead - Raw Materials (GMP)

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

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.