Quality Assurance Specialist

Quality Assurance Specialist

Warrington, PA

Overview

Salary Range $76,900.00 - $92,300.00 Salary Level Entry Position Type Full Time Job Shift M-F / 1st shift Education Level 4 Year Degree Travel Percentage None Category QA - Quality Control

Description

Polysciences' technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. We are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards® Management System. We believe the best scientific innovations are built through collaborations.

The Quality Assurance (QA) Specialist is responsible for ensuring that the company's products and processes comply with internal quality standards and external regulatory requirements. This role involves conducting audits, implementing quality processes, and collaborating with cross-functional teams to maintain and improve the quality management system. The QA Specialist will work to identify, resolve, and prevent quality issues to ensure product consistency, safety, quality, and compliance.

Essential Functions:

• Implement and maintain the company's quality management system (QMS) in compliance with applicable regulations, such as ISO 13485, 820 GMP, and FDA requirements.
• Manages Quality Systems (NC, CAPA, Change Control, etc.) and serves as QA approver to ensure implementation of compliant solutions and adherence to QMS requirements.
• Conduct internal audits and participate in external audits, ensuring compliance with established standards identifying areas for improvement.
• Assist in the development, review, and approval of Standard Operating Procedures (SOPs), Work Instructions (WI), batch records, and other quality-related documents involving technically complex issues and processes for accuracy and compliance with internal and external policies and regulations.
• Monitor and analyze production and quality data to identify trends, potential issues, and areas for improvement.
• Lead investigations into product non-conformities, customer complaints, and deviations. Develop and implement corrective and preventive actions (CAPAs) in collaboration with cross functional teams.
• Collaborate with Operations, R&D, and other departments to ensure products meet quality and regulatory requirements.
• Support the validation and qualification of processes, equipment, and products.
• Provide training and guidance to employees on quality standards, procedures, and best practices.
• Prepare reports and documentation for management review, audits, and regulatory submissions.
• Participate in continuous improvement initiatives to enhance product quality and operational efficiency.
• Review, approve and/or reject incoming materials, in-process materials and finished product.
• Perform all other quality related duties as assigned.

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.