QA Specialist

Summary

The Quality Assurance Specialist performs quality assurance functions specific to material disposition to ensure continuous production in accordance with established procedures, guidelines and standards. The QA Specialist is directly responsible for the QA oversight involving but not limited to the inspection and approval of materials, supporting the review of controlled documentation and providing support in internal inspections and walkthroughs.

Major Roles & Responsibilities

• Issues and reconciles all manufacturing labels and seals for Finished Goods Packaging.
• Issues or reviews Certificate of Analysis for Finished Goods Shipments.
• Performs Finished Good Inspection and/or QA Approval prior to Finished Good Shipments.
• Performs Finished Good Inspection Final Review upon completion of Finished Good Shipments.
• Notifies management of any non-conforming events and assists with writing or reviewing investigations.
• Communicates any quality related requirements or findings to applicable department staff to ensure the correction or prevention of non-conforming events.
• Inspects or reviews and assigns disposition for incoming components and raw materials.
• Approves and monitors the usage of regulated inventory in the electronic inventory system.
• Supports and implements the temporary operating instructions to be issued for quality activities.
• Recommends modification of existing quality or production standards to achieve optimum quality within limits of Manufacturing capability.
• Ensures Quality records are accurate, approved and in compliance with cGMP standards.
• Ensures that the facility is functioning in accordance with established quality policies and procedures through document review and approval, quality walkthroughs, communication with personnel and training support.
• Inputs, reviews and analyzes specific batch and process data into various spreadsheets for product evaluation.
• Performs quality review of facility documentation including logbooks.
• Reviews and approves Temperature and Humidity reports for the McConnell facility.
• Reviews, evaluates and approves the pest control logbook and assessments.
• Reviews and approves Maintenance work orders and preventative maintenance documentation.
• Other duties may be assigned as deemed appropriate by management.

Qualifications

• Four-year degree in Science or related field or approved equivalent experience in a cGMP environment.
• Has knowledge and understanding of cGMP & ICH Q7.
• Knowledge of relevant software applications including MS Office and Minitab.
• Knowledge of office systems and procedures.
• Knowledge of Supplier Approval Programs.
• Ability to communicate effectively with customers, regulatory agencies or members of the business community regarding inquiries or complaints.
• Organized, Thorough, Neat.
• Confidentiality.