QA Specialist II

Company: ATR International
Location: Buffalo Grove
Posted on: January 16, 2022

Job Description:

We are seeking a QA Specialist II for a very important client.The primary function of the Quality Specialist is to assist in maintaining the quality system. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). Assist with administration and ensuring compliance to Quality Management Systems including:Complaints Coordination, Batch Release, Exception Reports, CAPA, Document Control, Surveillance, Testing, Batch and Sample Retention and Maintenance, Metric etc. Assist with other support duties as assigned. Actively monitors Third Party Manufacturers data and Support areas for compliance with internal Standard Operating Procedures (SOPs) and relevant regulatory (cGMP, ISO) regulations. Reviews GMP related documentation for compliance such as batch records and associated data related to product manufacturing, testing and release, validation protocols and reports, labels, product specifications and other documentation as required. Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations in the Manufacturing area as required. Maintains product complaint logs to identify and report recurring issues to quality assurance management and product development. Collaborate with other internal groups to respond to product inquiries and issues. Writes and revises SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations. Collaborates with members of the Quality Assurance team working on special projects. Participate on permanent and temporary teams which are process or project driven. Become familiar and subject matter expert on electronic support systems, TraqWise, GQMS, Team Center, compliance wire etc. Collect analysis and publish quality metrics. Provide data for support of budgetary submissions.Responsibilities: - Batch release- Complaint Coordination- Metric maintenance- Surveillance Program- Testing Program- Document Control- Exception Report and CAPA System- Batch and Sample Retention and Maintenance Requirement: The candidate will possess the following qualifications. - BS degree or 3-7 years equivalent experience- Minimum 2 years -Direct experience in a Quality or Regulatory Affairs role in a GMP related industry.

Keywords: ATR International, Buffalo Grove , QA Specialist II, Other , Buffalo Grove, Illinois