Quality Assurance Specialist

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:


* 5+ years working under a ISO 13485 and/or 21CFR820 regulations.


* Experience with Good Manufacturing Practices (GM...