Change Control Specialist Job at Kelly Science, Engineering, Technology & Telecom, Lansdale, PA

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  • Kelly Science, Engineering, Technology & Telecom
  • Lansdale, PA

Job Description

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.

  • Train and mentor new members of the team.

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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