Position Summary:

The primary purpose of this position is to analyze, process, review and approve product documentation within the Quality System. Responsible for maintaining department metrics. Assists with development and implementation of document control systems that maintain compliance to all regulatory requirements. Support and implement continuous improvement activities associated with the Change Management process at the Durham site. Training advocate for internal customers to ensure proper GMP compliance in editing and revising quality records.

Primary Responsibilities:

• Provide technical assistance to owning departments (e.g. Industrialization, Facilities, Manufacturing)

• Perform QA Assessments for change controls

• Maintain department monthly and quarterly metrics

• Serve as SME on Durham Change Control Process and interface with customers and regulatory agencies for Inspections and Audits (MDSAP, FDA, ISO, Customer, etc)

• Process document requests for Iron Mountain

• Support QMS Activities by participating in cross functional projects/activities

• Support site Key Performance Indicators/metrics of Change Management and Document Control Processes

• Implement continuous improvement programs/projects for site Document Control Processes

• Perform any additional job related duties as requested

• Serve as backup to Site Referent, Document Control Authority, and Document Control Manager

• Perform all work in compliance with company quality procedures and standards.

  Education, Skills, & Experience:

• BA/BS Degree required, preferably in a science related field and a minimum three (3) years of experience in documentation and change management and working FDA regulated environment with knowledge of Good Manufacturing Practices required

• Prior work history with Electronic Quality Management System (eQMS) Software solutions preferred

• Demonstrated ability in providing compliant and practical solutions to complex issues

• Knowledge of Quality Engineering Tools and Techniques as well as TrackWise preferred

• Computer skills required, Microsoft Office

• Driving closure to achieve compliance with site and regulatory standards

• Excellent interpersonal skills and ability to work with all levels of an organization

• Ability to work independently and in a team environment

• Ability to prioritize and balance multiple deadlines in a fast-paced deadline driven environment

• Ability to work effectively and efficiently toward goal completion in a complex, diverse environment

• Ability to effectively communicate verbally and in writing; technical writing skills preferred