Quality Assurance Specialist

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

Job Details: Level: Experienced, Job Location: Warrington, PA 18976, Position Type: Full Time, Education Level: 4 Year Degree, Salary Range: $76,900.00 - $92,300.00 Salary, Travel Percentage: Negligible, Job Shift: M-F / 1st shift, Job Category: QA - Quality Control

Help Us Deliver Quality That Makes a Difference

At Polysciences, Inc., quality is at the heart of everything we do. Since 1961, we have been developing and manufacturing specialty chemicals and advanced materials that support innovation in life sciences, diagnostics, medical devices, electronics, and research.

We are seeking an experienced and detail-oriented Quality Assurance (QA) Specialist to join our team in Warrington, Pennsylvania.

In this role, you'll play an important part in maintaining and improving our Quality Management System (QMS), ensuring regulatory compliance, and supporting the consistent production of high-quality products. You'll work closely with Manufacturing, R&D, and other departments to investigate quality issues, implement effective solutions, and drive continuous improvement.

This is an excellent opportunity for a quality professional who enjoys problem-solving, collaborating across teams, and making a meaningful impact in a regulated manufacturing environment.

What You’ll Do

Quality Systems & Compliance

• Maintain and improve the company's Quality Management System (QMS) in accordance with applicable ISO 13485, FDA, and GMP requirements.
• Manage key quality processes, including nonconformances, corrective and preventive actions (CAPAs), change controls, and deviations.
• Review and approve quality documentation to ensure compliance with internal procedures and regulatory standards.
• Review and determine the disposition of incoming materials, in-process materials, and finished products.

Audits & Regulatory Readiness

• Conduct internal quality audits and support external audits and regulatory inspections.
• Identify compliance gaps, recommend improvements, and help ensure timely resolution of audit findings.
• Maintain accurate documentation and support audit readiness across the organization.

Investigations & Continuous Improvement

• Lead investigations into product nonconformities, customer complaints, and process deviations.
• Partner with cross-functional teams to identify root causes and implement effective corrective and preventive actions.
• Analyze quality and manufacturing data to identify trends, mitigate risks, and improve processes.
• Participate in continuous improvement initiatives that enhance product quality and operational efficiency.

Documentation & Cross‑Functional Support

• Develop, review, and approve Standard Operating Procedures (SOPs), work instructions, batch records, and other quality documentation.
• Support process, equipment, and product validation and qualification activities.
• Collaborate with Manufacturing, R&D, Engineering, and other teams to ensure quality requirements are understood and consistently met.
• Provide training and guidance to employees on quality procedures, regulatory requirements, and best practices.
• Prepare quality reports and documentation for management reviews and regulatory activities.

What We’re Looking For

Required Qualifications

• High school diploma or GED.
• 5+ years of experience working in an environment regulated under ISO 13485 and/or 21 CFR Part 820.
• Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Experience supporting internal and external audits and maintaining regulatory compliance.
• Familiarity with quality management processes, including CAPAs, nonconformances, change controls, and investigations.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across departments.
• Ability to manage multiple priorities, projects, and quality systems in a fast-paced manufacturing environment.
• Proficiency in Microsoft Office and document management systems.

Preferred Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, Quality Assurance, or a related scientific or technical field.
• Lead Auditor certification or relevant ISO 13485:2016, 21 CFR Part 820, or 21 CFR Parts 210/211 training or certification.
• Experience working in specialty chemical, pharmaceutical, medical device, or other regulated manufacturing environments.
• Experience with electronic Quality Management Systems (eQMS) for document control, CAPA management, training, and change control.
• Familiarity with Enterprise Resource Planning (ERP) systems for tracking materials, suppliers, and customer complaints.
• Experience supporting validation and qualification activities.

Why Join Polysciences?

At Polysciences, you'll be part of a collaborative team dedicated to quality, innovation, and continuous improvement. Our work supports industries and technologies that make a difference around the world.

We value individuals who take ownership of their work, bring new ideas to the table, and are committed to maintaining the highest standards of quality.

Ready to make an impact?

If you're a quality professional who thrives in a hands‑on manufacturing environment and enjoys turning challenges into improvements, we’d love to hear from you.