Quality System Specialist

Description:

• A typical day for the candidate involves actively supporting Quality Operations through a mix of hands-on floor engagement and strategic oversight. They begin the day by attending Tier 2 Gemba meetings and providing real-time support to manufacturing teams, ensuring compliance with quality standards.
• Their 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. The candidate also ensures training compliance, chairs Material Review Board (MRB) meetings, participates in Environmental Control Meetings, coordinates Quality Notifications (QNs), supports internal and external audits, and updates quarterly quality metrics.
• This role requires strong collaboration, attention to detail, and the ability to lead and influence cross-functional teams to uphold product and process integrity.

How You'll Make An Impact:

• Driving Compliance and Risk Mitigation: QA Specialist IIIs are instrumental in ensuring that products and processes meet regulatory and internal quality standards.
• Enhancing Product and Process Quality: By reviewing batch records, managing quality documentation, and participating in root cause analysis, QA Specialist IIIs help identify and correct systemic issues.
• Acting as Subject Matter Experts: QA Specialist IIIs are designated as the primary experts for specific product regulatory compliance, in accordance with ISO13485 standards.
• Supporting Internal /External Audits - They play a key role in audit readiness , in the Client's requalification process, QA specialists coordinated responses to audit requests and ensured timely delivery of quality documentation
• Strategic Quality Planning- working independently while collaborating across departments. They audit and review quality data, implement standards, and document results in regulated formats

What You Bring:

• 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.