Global Product Quality Materials Associate

Job Summary

Reporting to the Director Global Product Quality Materials, Associate is responsible for establishing and maintaining quality of raw materials and consumables to permit Moderna manufacturing locations to make consistent and reliable disposition decisions based on specifications and raw material management. This individual will work closely with MST, Process Development, Analytical Development, Supply Chain, Manufacturing, Regulatory, Quality Control, and Suppliers to ensure all aspects of Raw Material Quality Assurance are successfully executed.

• Location:
  
  Norwood, Massachusetts
• Job type:
  Contract
• Salary: $30 - $38 per hour
• Work hours:
  
  9 to 5
• Education:
  
  Bachelors

• Assist the material supplier management process for all raw material and consumable suppliers including onboarding and qualification activities.
• Support the supplier change notification process and ensure notifications are assessed for impact based on risk.
• Support Supplier Corrective Action Request (SCAR) process by issuing supplier complaints and drive for resolution and corrective actions.
• Support quality agreement execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements.
• Support raw material qualification program and management of raw materials used in clinical and commercial programs.
• Support the material onboarding process ensuring all relevant GxP regulations, guidelines, and company policies are followed and in compliance.
• Support change controls, corrective and preventative actions (CAPAs), and quality investigations involving raw materials by completing assigned actions.
• Review quality plans.
• Support investigations to provide root cause analysis and ensure effective corrective actions are taken.
• Ensuring compliance, and drive improvement plans where needed.
• 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.

• BA/BS in a scientific or engineering discipline.
• Experience:
  
  1-3 years of experience in pharmaceutical / biotech industry with Quality Assurance exposure preferred.
• Demonstrated aptitude or ability to learn to gain a strong understanding of GxP regulations.
• Skills:
  
  SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Assurance (QA).

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.