Change Control Specialist
Global Quality Large Molecule Analytical Sciences (GQLMAS) is seeking a motivated candidate to provide functional support for analytical change control activities for in-line products within biologics and vaccines. The candidate with a preferred scientific background will focus on analytical changes supporting in-line product analytical changes (e.g., method validations, specifications, method transfers, method improvement) with the opportunity to provide technical and laboratory support when needed.
Primary Responsibilities:
• Manage analytical change control activities associated with in-line products and ensure change control compliance with all regulatory expectations and global procedures.
• Partnering with key stakeholders in Regulatory, Analytical, Technology, Supply Chain, Operations, and Quality to coordinate assessments and approval of analytical change controls.
• Develop change strategy through creation of change plan and tasks and maintain end-to-end oversight to drive progress and escalate where required.
Required Experience and Skills:
• Experience and understanding of change control environment and systems
• Work independently and within cross-functional teams.
• Effective organization to multi-task and manage multiple projects
• Strong collaborative and communication skills
• Effective written and oral communication skills
Education:
• BS degree required, concentrations in life sciences, engineering or related relevant discipline with relevant industry experience.
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