Quality Specialist II
Location: Hercules, CA (Onsite)
Schedule: MondayโFriday, 8:00 AMโ5:00 PM
Duration: 6-Month Contract with potential to extension/conversion
Pay: $40โ$45/hour DOE
Join a global leader in life sciences as a Quality Specialist II supporting a high-impact Quality Management System (QMS) migration project. In this role, you will help transition quality documentation from a legacy system to Veeva Quality Docs while ensuring compliance with FDA and ISO regulations. This is an excellent opportunity for a quality professional with experience in regulated manufacturing, document control, and quality systems who enjoys working cross-functionally on process improvement initiatives.
What You'll Do
- Support the end-to-end migration of quality documentation, SOPs, and records from a legacy QMS into Veeva Quality Docs.
- Map documents, configure metadata, and validate migrated records to ensure accuracy, completeness, and compliance.
- Conduct gap assessments on legacy documentation and identify remediation needs prior to migration.
- Coordinate cross-functional meetings with Quality, Regulatory, Operations, and project stakeholders to track migration progress and resolve issues.
- Execute User Acceptance Testing (UAT), document test results, and troubleshoot migration discrepancies.
- Train end users on new QMS workflows and provide post-go-live support.
- Maintain document traceability and support the controlled retirement of the legacy system.
- Ensure compliance with GMP, ISO 13485, FDA 21 CFR 820/210/211, and internal quality requirements.
- Help maintain an audit-ready quality system throughout the migration project.
Qualifications
- Associate's degree in Biology, Chemistry, Engineering, or a related scientific discipline (or equivalent experience).
- 3+ years of experience in a regulated manufacturing environment (medical device, biotech, pharmaceutical, or life sciences).
- Experience working with Quality Management Systems (QMS) and controlled documentation.
- Familiarity with GMP, ISO 13485, FDA 21 CFR 820, 210, and 211 requirements.
- Experience with Veeva, SAP, or other electronic document management/QMS platforms.
- Strong project coordination and organizational skills with the ability to manage multiple priorities.
- Excellent communication skills and the ability to collaborate across cross-functional teams.
- High attention to detail and commitment to quality and compliance.
Preferred Experience
- Experience supporting QMS implementations or system migrations.
- Previous involvement with document control, validation, or quality systems projects.
- Experience participating in audits or maintaining inspection readiness.