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Kelly Science, Engineering, Technology & Telecom · 1 day ago

Change Control Specialist

Lansdale, PA

Full-time

Onsite

Mid Level

Kelly Science, Engineering, Technology & Telecom is seeking a motivated Change Control Specialist to provide functional support for analytical change control activities for in-line products within biologics and vaccines. The role focuses on managing analytical change control activities, ensuring compliance, and collaborating with various stakeholders to drive progress and support the team.

Staffing & Recruiting

Hiring Manager

Kellie Pharr

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

Qualification

Change control systemsAnalytical method validationProject managementCollaborationCommunication skills

Required

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

BS degree required, concentrations in life sciences, engineering or related relevant discipline with relevant industry experience

Preferred

Preferred scientific background will focus on analytical changes supporting in-line product analytical changes (e.g., method validations, specifications, method transfers, method improvement)