Senior QA Specialist — ISO & Regulatory Compliance

Polysciences, Inc.; Warrington Township (Bucks County); On-site; USD 77,000 - 92,000; Full time

Job summary

Polysciences, Inc. in Warrington, PA, seeks an experienced QA Specialist to maintain and improve the Quality Management System (QMS), ensuring regulatory compliance and consistent production of high-quality products.

You will work with Manufacturing, R&D, and other departments to investigate quality issues, drive continuous improvement, and lead investigations into nonconformities and customer complaints, contributing significantly to product quality in a regulated environment.

Qualifications

• High school diploma or GED.
• 5+ years of experience in ISO 13485 and/or 21 CFR Part 820.
• Working knowledge of GMP and GDP.
• Experience supporting internal and external audits and regulatory compliance.
• Familiarity with CAPAs, nonconformances, change controls, and investigations.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication with cross-department collaboration.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.
• Proficiency in Microsoft Office and document management systems.

Responsibilities

• Maintain and improve the QMS in accordance with ISO 13485, FDA, and GMP requirements.
• Manage CAPAs, nonconformances, change controls, and deviations.
• Review and approve quality documentation to ensure compliance with procedures.
• Review and determine disposition of incoming, in-process, and finished materials.
• Conduct internal quality audits and support external audits and regulatory inspections.
• Identify compliance gaps and implement improvements; ensure timely resolution of findings.
• Maintain accurate documentation and audit readiness across the organization.
• Lead investigations into product nonconformities and customer complaints; identify root causes.
• Collaborate with cross-functional teams to implement corrective and preventive actions.
• Analyze quality and manufacturing data to identify trends and mitigate risks.
• Support validation and qualification activities.

Skills

Regulatory compliance

CAPA management

Audits

QMS

Documentation

Root cause analysis

Education

Bachelor's degree in Chemistry, Biology, Engineering, Quality Assurance, or related

Tools

eQMS

ERP systems

Document management systems

Job description

Polysciences, Inc. in Warrington, PA, seeks an experienced QA Specialist to maintain and improve the Quality Management System (QMS), ensuring regulatory compliance and consistent production of high-quality products.

You will work with Manufacturing, R&D, and other departments to investigate quality issues, drive continuous improvement, and lead investigations into nonconformities and customer complaints, contributing significantly to product quality in a regulated environment.