Quality Assurance Specialist
Melville, NY 11747
- Maintains processes/procedures to ensure compliance to internal and external requirements. Provides compliance support for Quality Assurance, Regulatory Affairs, R&D, and Operations to assure regulatory compliance and appropriate business planning.
- Creates, authors, and monitors CAPAs and NCRs as required. Assists manager in creating measurable data for periodic reviews of Quality System
- Leads and maintains process to carry out the creation, review, revision, approval, release and implementation of change orders within the Document Control System.
- Leads and maintains processing of change orders and other required documentation in support of the Quality system process/records compliance.
- Provides training support in quality concepts and tools. Participates in and, where necessary, drives continuous improvement of the quality processes.
- Supports review of policies and procedures to ensure compliance with government regulations and international Quality System Regulations (QSR) including International Organization for Standardization (ISO) quality system standards.
- Provides project management leadership to various Quality-driven initiatives and represents Quality as-needed for representation in company-wide improvement initiatives.
- Actively leads audit preparation efforts by executing planning, gap analysis, and mitigation implementation activities required to comply with new regulations and standards.
- Responsible for supporting generation of QMS documentation using Electronic Document Management System (EDMS). Supports coordination of document and record retention program for the site in alignment with the client’s corporate requirements.
- Writes and revises Quality Systems procedures, performs gap assessments and assists in driving compliance. Understanding of manufacturing procedures and GMP requirements are required.
- Must have experience in Change Management, Inspection and CAPA Management. Exposure to internal, external, laboratory, supplier auditing programs as appropriate.
- Minimum of 6 years related experience in a regulated industry,
- Experience in pharmaceutical, medical devices, or other regulated industry background
- Degree Preferred