Senior QA Specialist QC Laboratory Equipment Qualification (CQV)

Career Soft Solutions Inc; Norwood (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Moderna Norwood, MA is seeking a Senior Specialist, Quality Assurance for Quality Control. You will provide quality oversight for QC equipment moves, qualification activities, and decommissioning across Norwood sites, supporting QC lab instrument activities.

Responsibilities include reviewing QC documentation, ensuring data integrity, following GxP guidelines, SOPs, and training, and handling deviations, change controls, and documentation. FDA/ICH knowledge is preferred.

Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field
• 3–8 years experience in CQV activities within biotech/pharma or regulated GMP environments
• Familiarity with QC equipment qualification/CQV activities and good documentation practices

Responsibilities

• Review and approve QC equipment documentation (qualification/validation protocols, reports, forms, data tables) to ensure readiness and data integrity
• Review QC logbooks and ensure compliance with GxP regulations and company policies
• Identify, review, and approve deviations, change controls, CAPAs, and other QC-related documents
• Ensure data integrity and proper documentation; follow SOPs and training requirements
• Support QC instrument activities and ensure compliance with regulatory requirements

Skills

Quality Assurance

CQV

GxP

Data Integrity

Deviation management

Change control

Documentation

Education

Bachelor's Degree

Tools

Kneat

Microsoft Office

Statistical software

Job description

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.