Quality Assurance Specialist

Polysciences, Inc.•Warrington Township, PA

23d•$76,900 - $92,300•Onsite

About The Position

Polysciences, Inc. is seeking an experienced, detail-oriented Quality Assurance Specialist to work in its Warrington, Pennsylvania manufacturing environment. The role maintains and improves the Quality Management System (QMS), supports regulatory compliance, and helps ensure consistent production of high-quality products. The specialist works with Manufacturing, R&D, Engineering, and other departments to investigate quality issues, implement solutions, and advance continuous improvement. The position manages quality processes such as nonconformances, corrective and preventive actions (CAPAs), change controls, and deviations; reviews quality documentation and product disposition; conducts internal audits and supports external audits and regulatory inspections; and leads investigations into product nonconformities, customer complaints, and process deviations. The specialist also analyzes quality and manufacturing data, supports validation and qualification activities, develops and approves quality documents, trains employees, and prepares quality reports for management and regulatory activities. The position is full-time, Monday through Friday on the first shift, with negligible travel. The stated salary range is $76,900 to $92,300. The immediate work environment may include chemicals, unprotected heights, fumes or gases, and persistent noise. The listed work activities are sitting continuously for six hours and standing and walking intermittently for one hour each. Lifting or carrying 0–10 pounds is listed as less than one hour per day; 11–25 pounds is rare, and heavier ranges are never required.

Requirements

High school diploma or GED.
At least 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 CAPAs, nonconformances, change controls, and investigations.
Strong analytical, problem-solving, and organizational skills.
Excellent written and verbal communication skills and ability to collaborate 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.

Nice To Haves

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 in specialty chemical, pharmaceutical, medical device, or other regulated manufacturing environments.
Experience with electronic QMS systems for document control, CAPA management, training, and change control.
Familiarity with ERP systems for tracking materials, suppliers, and customer complaints.
Experience supporting validation and qualification activities.

Responsibilities

Maintain and improve the company's QMS in accordance with applicable ISO 13485, FDA, and GMP requirements.
Manage nonconformances, CAPAs, change controls, and deviations.
Review and approve quality documentation for compliance with internal procedures and regulatory standards.
Review and determine the disposition of incoming materials, in-process materials, and finished products.
Conduct internal quality audits and support external audits and regulatory inspections.
Identify compliance gaps, recommend improvements, and help resolve audit findings in a timely manner.
Maintain accurate documentation and support organizational audit readiness.
Lead investigations into product nonconformities, customer complaints, and process deviations.
Partner with cross-functional teams to identify root causes and implement corrective and preventive actions.
Analyze quality and manufacturing data to identify trends, mitigate risks, and improve processes.
Participate in continuous improvement initiatives to enhance product quality and operational efficiency.
Develop, review, and approve 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 met.
Provide employee training and guidance on quality procedures, regulatory requirements, and best practices.
Prepare quality reports and documentation for management reviews and regulatory activities.