Quality Assurance Specialist

Title: Senior Specialist, Quality Assurance for Quality Control

Reports to: Director, Quality Assurance for Quality Control

Function/Department: Global Drug Substance QA

Regulatory Relevance: GxP

Location: Norwood, MA

The Role: (Summary)

In this role, you will be responsible for providing quality oversight, guidance, and decision-making for Quality Control (QC) equipment moves, qualification activities and decommissioning activities across Moderna Norwood sites. This individual is a key member of the Quality Assurance for Quality Control team, building a culture of quality in our GxP and GMP laboratories. This Sr. Specialist of QA for QC provides support primarily for Norwood QC lab instrument activities.

Key Responsibilities and if appropriate Authorities of the Position:

• Reviews and approves documentation associated with QC laboratory equipment, including qualification/validation protocols and reports, periodic reviews, method SOPs, forms, and data tables, to ensure equipment readiness, data integrity, and compliance with applicable regulations and cGMP requirements.
• Reviews QC logbooks.
• Follows 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.
• Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
• Ensures QC personnel follow Good Documentation Practices and Data Integrity requirements.
• Identify, assess, classify, review, and approve deviations, change controls, work orders, SOPs, CAPAs and other documents related to QC equipment/instrument activities.
• Make quality decisions to ensure compliance with internal procedures and external regulations.
• 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.

Required Background:

• Education: Bachelor’s degree in biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field.
• Experience: 3-8 years' experience in CQV activities within the biotechnology/biopharmaceutical industry, or other regulated industry within a GMP environment. Preferably in Quality Assurance and/or Quality Control.
• Specific Certifications or Training: None
• Knowledge of FDA, EU, ICH guidelines, and relevant regulations.
• Familiarity with equipment qualification/CQV activities.
• Experience in analytical or microbiological general QC testing or analytical techniques, method validation, and method transfer.
• Experience with deviation management, change control, risk management and digital solutions for quality systems.
• Proficiency in Kneat (or equivalent software application), Microsoft Office tools and statistical programs/software.
• Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.