Senior QA Specialist - GMP, ISO 13485, Audits

Polysciences, Inc.; Florida; On-site; USD 80,000 - 110,000; Full time

Job summary

Polysciences, Inc. is seeking a QA Specialist in Warrington, PA to maintain and improve the QMS, ensuring regulatory compliance and production of high-quality products. You will investigate issues, lead CAPAs, and drive continuous improvement across Manufacturing, R&D, and other teams.

The role emphasizes cross-functional collaboration, adherence to ISO 13485 and GMP, and strong documentation practices to support audits and regulatory activities.

Qualifications

• Experience in ISO 13485 and 21 CFR Part 820 environments.
• Strong knowledge of GMP and GDP practices.
• Experience supporting internal and external audits and regulatory compliance.
• Familiarity with CAPAs, nonconformances, change controls, and investigations.
• Excellent written and verbal communication across departments.

Responsibilities

• Maintain and improve the company's QMS in line with ISO 13485, FDA, and GMP.
• Manage nonconformances, CAPAs, change controls, and deviations.
• Review quality documentation for compliance and approve records.
• Lead investigations into product nonconformities and customer complaints.
• Support audits and regulatory inspections with accurate documentation.
• Collaborate with Manufacturing, R&D, and Engineering to ensure quality requirements.

Skills

Analytical thinking

Problem solving

Organizational skills

Communication skills

Cross-functional collaboration

MS Office

Education

Bachelor's degree in Chemistry

Bachelor's degree in Engineering

Tools

eQMS

ERP systems

Document management systems

CAPA software

Job description

Polysciences, Inc. is seeking a QA Specialist in Warrington, PA to maintain and improve the QMS, ensuring regulatory compliance and production of high-quality products. You will investigate issues, lead CAPAs, and drive continuous improvement across Manufacturing, R&D, and other teams.

The role emphasizes cross-functional collaboration, adherence to ISO 13485 and GMP, and strong documentation practices to support audits and regulatory activities.