Quality Assurance Specialist

About the role

The Quality Assurance (QA) Specialist at Polysciences ensures compliance 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.

Responsibilities

• Implement and maintain the company’s quality management system (QMS) in compliance with applicable regulations, such as ISO 13485, 820 GMP, and FDA requirements.
• Manage Quality Systems (NC, CAPA, Change Control, etc.) and serve as QA approver to ensure implementation of compliant solutions and adherence to QMS requirements.
• Carry out internal audits and participate in external audits, ensuring compliance with established standards and identifying areas for improvement.
• Aid 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

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

What We Offer

• Culture: Great people, Peer to Peer Recognition, Broader, hands-on work experience, Clean and Modern Equipment & Labs, Fun company events
• Benefits: Competitive Wages & Generous Year-end Bonus, Comprehensive Benefits, 3 PPO Medical Plans with Telemedicine, Rx, & Vision, 2 Dental Plans, Healthcare, Dependent care, & Commuter, Flexible Spending Accounts, 401(k) with company match, Financial Health & Wellness w/1:1 Coaching & Rewards, Basic & Supplemental Life Insurance, Accident, Hospital Indemnity, & Critical Illness, Paid Time Off, Paid Parental Leave, Short & Long-term Disability, 9 Paid Holidays