Control Specialist

Senior Clinical Recruiter at Kelly Services 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.

• Manage analytical change control activities associated with in‑line products and ensure change control compliance with all regulatory expectations and global procedures.
• Partner 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 a change plan and tasks and maintain end‑to‑end oversight to drive progress and raise issues where required.
• Train and mentor new members of the team.

• 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.

Associate

Full‑time

Analyst, Manufacturing, and Project Management

Pharmaceutical Manufacturing

• 401(k)
• Vision Insurance
• Medical Insurance

Lansdale, PA