Senior QA Specialist QC Laboratory Equipment Qualification (CQV)

Senior Specialist, Quality Assurance for Quality Control

Location: Norwood, MA

6- 12 Months Contract

W2 only

++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.