Change Management Analyst
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POST DATE 8/25/2016
END DATE 12/19/2016
JOB DESCRIPTIONDuties may include oversight of various aspects of change control and documentation, including but not limited to validation change administration, records management, document control, local change control, and corporate change control. As a member of the Quality unit this individual is accountable for ensuring that changes made to processes, products or systems have been properly reviewed and approved to maintain proper cGMP control of validated systems. The Specialist will be responsible for the oversight of change control activities supporting multiple projects, ensuring timely completion of deliverables and effectively escalating any issues impacting those projects.
ESSENTIAL JOB FUNCTIONS:
1. Administers the local change control system, validation change control system, records management system, and/or documentation system.
2. Corporate changes relating to Austin processes are reviewed for impact and that Austin commitments are appropriately tracked to completion
3. Ensures consistency and compliance of changes with local, corporate and global regulatory requirements (CFR, PIC/s, etc)
OTHER DUTIES AND RESPONSIBILITIES:
1. Come to agreement by managing communications through discussions and compromise.
2. Write or assist with the writing of Standard Operating Procedures
3. Perform other related duties as assigned or required.
* 3-5 years of Quality experience in a regulated environment (FDA regulated environment preferred).
* High level of attention to detail and the ability to prioritize and manage heavy workloads in a dynamic environment.
* Must have thorough knowledge and understanding of cGMPs, FDA and/or pharmaceutical industry guidelines.
* Must have good organizational, presentation, project management, and meeting facilitation skills.