Quality Assurance Specialist

Help Us Deliver Quality That Makes a Difference

AtPolysciences, 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-orientedQuality 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.

Apply today and help us continue delivering quality through innovation.

Qualifications

Qualifications

Education Required: High School Diploma/GED                                                Preferred: Bachelor's Degree                          

Certification(s): Specify preferred or required.

Preferred Lead Auditor or applicable ISO 13485:2016 / 21 CFR 820 or 210/211 Certification

Computer Skills Required:Specify preferred or required.

Proficiency with document management software and Microsoft Office Suite.

Preferred experience with Enterprise Resource Planning (ERP) systems for tracking suppliers, materials, and customer complaints.

Preferred experience with electronic QMS systems for tracking, reviewing and approving documents, training quality issues, CAPA, effectiveness checks, and change controls.

Other qualifications:

• 5+ years working under a ISO 13485 and/or 21CFR820 regulations.
• Experience with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Strong analytical and problem-solving abilities.
• Highly organized and detail-oriented, with the ability to manage multiple tasks, systems and projects simultaneously.
• Strong written and verbal communication skills to interact effectively with various departments, such as Quality, Operations, and Engineering/Facilities.
• Experience with audit preparedness and support during internal and external audits.

Immediate Work Environment:

Chemicals                    Unprotected Height            Fumes/Gases           Persistent Noise

  PPE used: Click or tap here to enter text.

Work Activity: [must equal number of hours worked per day]       

Stand:     1            Frequency:  Intermittently                           Walk:     1            Frequency:  Intermittently    

Sit:         6            Frequency:  Continuously                            Drive:      0            Frequency:  Choose an item.              

Life/Carry Demands

Frequency:                                                      Lift/Carry Equipment Provided:

0-10 lbs.                             Less than 1 hour a day                   Click or tap here to enter text.

11-25 lbs.            Rarely                   Click or tap here to enter text.

26-50 lbs.            Never                   Click or tap here to enter text.

51-75 lbs.            Never                   Click or tap here to enter text.

76-100 lbs.          Never                   Click or tap here to enter text.