Quality Systems Specialist II

Responsibilities

• 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 ISO
  13485 standards.
• Supporting Internal /External Audits - They play a key role in audit readiness , in the Bio-Rad 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

• 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.

Compensation: $40-45 per hour while on contract