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UA QA Associate

Company: Union Agener, Inc.
Location: Augusta
Posted on: July 16, 2019

Job Description:

Job Description - Union Agener QA AssociateSupervisor Title: QA ManagerPosition Type: Full timeLocation: Union Agener, Inc. - Augusta, GA 30901 Position Description, Functions, Duties, and Tasks:-- Oversee specific systems or functional areas as assigned-- Prepare, review, redline, and/or approve GMP documents supporting the site (procedures, specifications, protocols, reports, change controls, deviations, etc.)-- Implement and maintain systems for complete documentation and control of all required records, logs, and instructions necessary for compliance with cGMP-- Leads activities in the control and maintenance of the QA archiving systems for cGMP operations-- Implement and maintain systems to support the stability program-- Evaluate the quality impact for any GMP related incidents, triage initial corrective actions, and support the long term resolutions-- Participate in self led and/or regulatory inspections -- Educate site personnel on quality matters-- Function as the back-up for other QA colleagues Minimum Qualification (education, experience and/or training, required certifications):Education:-- Bachelor of Science degree (4 year college)Experience: -- Demonstrated relevant experience (Quality Assurance, Quality Control, Engineering, Operations, Technology) in a manufacturing facility regulated by the FDA and in compliance with cGMP-- Excellent verbal and written communication skills tailored to the appropriate audience-- Ability to work well at all levels within the organization, comfortable in a manufacturing environment-- Good interpersonal skills, planning, organization and prioritizing are essential-- Team building skills, along with the ability to facilitate action plans-- Must have knowledge of computer systems and software applications, including Microsoft Office applications Additional Preferences:-- Demonstrated Project Management Skills -- Detailed and Results Oriented-- Solid Computer Skills - Microsoft Office / SAP / SE Suite-- Strong Interpersonal Skills-- Ability to Work Effectively with Respect for Others in a Team Environment-- Excellent Communication and Organization Skills-- Adapt readily to change and have the desire to experience New Challenges and Opportunities-- This position must provide hands-on support to all plant personnel in a 24/7 work environment and be on call to provide "over the phone" or "on site" support and direction.-- Must be able to travel to all areas of the plant which may include walking, climbing various levels of stairs or ladders, at various floor levels in various buildings as well as the exterior of the building. Other Information: -- Initial assignment will be in one of two Quality Assurance roles:-- Documentation & Archive-- Stability Program

Keywords: Union Agener, Inc., Augusta , UA QA Associate, Other , Augusta, Georgia

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