Job description – QA Specialist II – Change Controls

Assist change request owners with analyzing requirements for change requests and assesses resulting impacts to company. Ensures information to be presented to change control request board (CCRB) is adequately prepared for the CCRB to review in order accept, reject or postpose proposed changes. Must be a team player and able to work collaboratively with others.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Communicates relevant information to management team and solicits input and feedback regarding upcoming change requests
  • Takes lead role in representing the change control department through interfacing with other functional units across the company
  • Takes lead role in representing the change control department through interfacing with other existing clients
  • Actively participate in effective arrangement of the Change Control System (proposing, initiation, implementation, closure) of change controls.
  • Ensuring the company’s & client’s interests needs pertaining to a change request are known and accommodated based on change request information
  • Engages internal and external communication, subject matter experts and management as needed to drive effective change requests
  • Responsible for day-to-day management of change request documentation
  • Provides daily updates for change control metrics for site metrics
  • Updates the Quality Performance Boards daily
  • Maintains the Change Control Log spreadsheet

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Minimum 2 year degree (AS or AAS) in Life Sciences or related field
  • Minimum of 2 years GMP related experience in biopharmaceutical/ pharmaceutical or related industry
  • Has an understanding of the fundamentals of change and change management and how to apply those practices within the company
  • Thorough knowledge of FDA regulations and cGMP requirements
  • Must have effective oral & written communication skills
  • Ability to prioritize daily activities in order to meet client needs on time of established timelines in a fast-paced environment
  • Ability to influence others and move toward a common vision or goal of timely closures for change controls
  • Participate in the performance of internal and external audits in accordance with current regulatory compliance
  • Problem solving and root cause identification skills
  • Ability to monitor and report on assigned tasks, goals, and objectives
  • Experience with large-scale organizational change efforts
  • Flexible and adaptable; able to work in ambiguous situations
  • Computer skills/ data analysis skills (Word, Excel, PowerPoint) are required

 

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