Quality Specialist

Overview

This is an exciting opportunity to join a global, industry leading company. The Quality Specialist will support Quality Operations through a mix of hands-on floor engagement and strategic oversight. Responsibilities include performing batch record reviews and product releases, reviewing and approving stability studies and labeling (such as FAI and field bulletins), and offering guidance on regulatory standards. This role requires strong collaboration, attention to detail, and the ability to lead and influence cross-functional teams to uphold product and process integrity.

• 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 III is designated as the primary expert for specific product regulatory compliance, in accordance with ISO 13485 standards.
• Support internal/external audits; play a key role in audit readiness and the requalification process. QA specialists coordinate responses to audit requests and ensure timely delivery of quality documentation.
• Strategic quality planning: work 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.

• Associate degree or equivalent in Biology, Chemistry, or a related field.
• 2+ 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.
• Experience with nonconformance investigations, deviation management, batch record review, and product release.
• Proficiency in QMS databases, SAP, Veeva and Microsoft Office.
• Strong attention to detail, multitasking, time management, and communication skills.

Pay Range (Based on Experience & Qualifications): $40 - $45 per hour