Job description – QA Specialist I – Change Controls

Assist supervisor with following-up on change requests which that are in the implementation (execution) phase in order to ensure on time change request closures. Must be a team player and able to work collaboratively with others.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Assists immediate supervisor and/ or Quality Specialist II with understanding and gathering requirements to process change requests
  • Processes change control records in accordance with current good documentation practices (cGDP)
  • Acts as the document control coordinator / administrator for documents associated with a change request (upload documents in Master Control and ensure documents are routed to the correct approvers)
  • Monitors the status of uploaded documents in Master Control to ensure documents move through approvals in a timely manner (may need to contact individuals for their approvals)
  • Participate in the arrangement of scheduling closure meetings for change requests
  • Responsible for day-to-day management of change request documentation
  • Provide summary information pertaining to change request statuses (change requests that are overdue and pending information) to appropriate area supervisors/ managers
  • Maintains the Change Control Log spreadsheet

 

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

  • Minimum 1 year certificate (degree) in Life Sciences (or related field) OR working 2 years in a Quality Assurance/ Quality Control position
  • 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
  • Basic knowledge of FDA regulations 21 CFR 820 (Subpart A: General Provisions and D: Document Controls)
  • Must have effective oral & written communication skills
  • Experience working with Master Control document control software
  • Ability to prioritize daily activities in order to meet client needs on time of established timelines in a fast-paced environment
  • Ability to monitor and report on assigned tasks, goals, and objectives
  • Flexible and adaptable; able to work in ambiguous situations
  • Computer skills/ data analysis skills (Word & Excel) are required

 

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