Quality Specialist II - Temporary

About the role

A typical day for the Quality Specialist II is centered on executing and supporting the full lifecycle migration of the Quality Management System from Legacy System to New Platform. The candidate works closely with cross-functional stakeholders to map existing Legacy documents and records into the New Platform, configure document hierarchies and metadata, and validate migrated content for accuracy and compliance.

Responsibilities

• Executing and supporting the full lifecycle migration of the Quality Management System from Legacy System to New Platform
• Making sure all controlled documents remain accessible and audit-ready throughout the transition
• Leading and coordinating stakeholder meetings across QA, Regulatory, and Operations to review migrated documentation, align on content accuracy, resolve discrepancies, and track migration milestones to ensure timely project completion
• Conducting structured gap analyses on legacy documents to identify compliance deficiencies against IVDR requirements, prioritizing remediation efforts, and ensuring all migrated content meets current regulatory standards before go-live
• Supporting UAT activities, documenting test results, and training end-users on Veeva Quality Docs workflows to ensure a smooth cutover and sustained system compliance post-migration
• Coordinating the controlled retirement of the Legacy platform, maintaining documentation traceability during transition, and ensuring the quality system remains inspection-ready for internal and external audits throughout the migration period

Requirements

• Associate degree or equivalent in Biology, Chemistry, Engineering, or a related field
• 3+ years of experience in a regulated manufacturing industry, or an equivalent combination of education and experience
• Familiarity with GMP and quality system standards (e.g., ISO 13485, FDA 21 CFR 820/210/211)
• Working knowledge of device/drug/biotech manufacturing processes
• Proficiency in QMS databases, SAP, Veeva, and Microsoft Office
• Strong attention to detail, project coordination skills, and the ability to manage multiple workstreams simultaneously while collaborating cross-functionally and influencing without authority during a system transition

Qualifications

• Strong communication and collaboration skills
• Ability to work independently and as part of a team
• Experience with regulatory compliance and documentation management
• Knowledge of regulatory requirements such as IVDR

Skills

• Project management
• System validation
• User adoption support
• Gap analysis
• Regulatory compliance

Benefits

Not specified

Pay

The estimated hourly range for this position is $40 to $43 per hour at the time of posting. Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.

Schedule

Not specified