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Cypress HCM · 18 hours ago

Quality Specialist

Hercules, CA

Contract

Onsite

Entry, Mid Level

$40/hr - $45/hr

2+ years exp

Cypress HCM is a global, industry leading company seeking a Quality Specialist to support Quality Operations. The role involves hands-on engagement and strategic oversight, including batch record reviews, product releases, and ensuring compliance with regulatory standards.

Human ResourcesInformation TechnologyStaffing Agency

Growth Opportunities

Responsibilities

Drive Compliance and Risk Mitigation:, ensure that products and processes meet regulatory and internal quality standards

Enhance Product and Process Quality by reviewing batch records, managing quality documentation, and participating in root cause analysis

Act as a Subject Matter Expert: QA Specialist IIIs are designated as the primary experts for specific product regulatory compliance, in accordance with ISO13485 standards

Supporting Internal /External Audits; play a key role in audit readiness , in the requalification process, QA specialists coordinate responses to audit requests and ensured timely delivery of quality documentation

Strategic Quality Planning; working independently while collaborating across departments. Audit and review quality data, implement standards, and document results in regulated formats

Ensure training compliance, chair Material Review Board (MRB) meetings, participate in Environmental Control Meetings, coordinate Quality Notifications (QNs), support internal and external audits, and update quarterly quality metrics

Qualification

GMP standardsISO 13485Quality Management SystemsRegulated manufacturing experienceSAPVeevaMultitaskingAttention to detailTime managementCommunication skills