QA Specialist II

Company: Cortech
Location: Buffalo Grove
Posted on: November 16, 2022

Job Description:

Start Time (AM/PM): 8:00AMEnd Time (AM/PM): 5:00PMThis position is Nonexempt. Hours over 40 will be paid at Time and a Half. Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices). BS degree or 3-7 years equivalent experience.The primary function of the Quality Specialist is to assist in maintaining the quality system.The role can have responsibility for one or more of the following processes:--- Batch release--- Complaint Coordination--- Metric maintenance--- Surveillance Program--- Testing Program--- Document Control--- Exception Report and CAPA System--- Batch and Sample Retention and MaintenanceMAIN RESPONSIBILITIES--- 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 Maintence, 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, TeamCenter, compliance wire etc.--- Collect analysis and publish quality metrics.--- Provide data for support of budgetary submissions.

Keywords: Cortech, Buffalo Grove , QA Specialist II, Other , Buffalo Grove, Illinois