ASP Global · 7 hours ago
Quality Operations Coordinator
Austell, GA
Full-time
Onsite
New Grad, Entry LevelASP Global is seeking a Quality Operations Coordinator to perform day-to-day quality functions in compliance with their Quality Management System. The role involves managing customer complaints, supporting supplier quality programs, and ensuring adherence to quality regulations.
Medical
Responsibilities
Manage Customer Complaint files including but not limited to root cause investigation, customer/field representative communication, supporting the contract manufacturer investigation and timely closure of complaint investigation files
Perform/coordinate in depth investigations to include root causes for situations identified as NCRs, CAPAs, SCARs or complaints
Support the Supplier Quality program by managing supplier quality files, including management of the supplier questionnaires
Generate and distribute periodic quality reports detailing the quality system performance
Oversee global corporate QMS training program
Assist in management of quality systems, including reviewing and revision of procedures, forms and other controlled documents
Maintain Document Control System and update policies and procedures to support continuous improvement and quality objectives
Maintain accurate Quality filing system and appropriate documentation to conform to quality and GMP regulations
Ensure containment activities are executed appropriately
Monitor the customer feedback inbox, ensure pertinent information is distributed appropriately
Support the customer service team by providing technical documentation when appropriate
Support rework and relabeling operations when necessary
Manage the Return Material Authorization process (RMA) in compliance with ASP Global procedures
Qualification
Required
Perform day to day quality functions in compliance with ASP Globals Quality Management System
Support compliance with FDA 21 CFR 820 through management of inspections, reworks, relabeling and kitting functions
Manage Customer Complaint files including but not limited to root cause investigation, customer/field representative communication, supporting the contract manufacturer investigation and timely closure of complaint investigation files
Perform/coordinate in depth investigations to include root causes for situations identified as NCRs, CAPAs, SCARs or complaints
Support the Supplier Quality program by managing supplier quality files, including management of the supplier questionnaires
Generate and distribute periodic quality reports detailing the quality system performance
Oversee global corporate QMS training program
Assist in management of quality systems, including reviewing and revision of procedures, forms and other controlled documents
Maintain Document Control System and update policies and procedures to support continuous improvement and quality objectives
Maintain accurate Quality filing system and appropriate documentation to conform to quality and GMP regulations
Ensure containment activities are executed appropriately
Monitor the customer feedback inbox, ensure pertinent information is distributed appropriately
Support the customer service team by providing technical documentation when appropriate
Support rework and relabeling operations when necessary
Manage the Return Material Authorization process (RMA) in compliance with ASP Global procedures
Attention to Detail - Thoroughness in accomplishing a task through concern for all the areas involved, no matter how small
Planning & Organizing / Time Management - Establishes a systematic course of action for self or others to ensure accomplishment of a specific objective
Collaboration - Develops cooperation and teamwork while participating in a group, working toward solutions which generally benefit all involved parties
Reliability - Demonstrates a high level of dependability in all aspects of the job
Company
ASP Global
ASP Global is a privately held, Atlanta-based company with additional operations in the Pacific Rim.
Founded in 2003
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Incline Equity Partners
2024-08-06Acquired
2020-02-11Private Equity
Leadership Team
Doug Shaver
Chief Executive Officer
Justin Martin
Chief Product Officer & General Manager, Injury Prevention
Recent News
2023-06-13
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