Remote Change Control Specialist, External Supply

Actalent

Thousand Oaks (CA)

Remote

USD 62,000 - 65,000

Full time

40 hours ago
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Benefits offered by this job

Medical, dental & vision
401(k) Retirement Plan
Time Off/Leave

Job summary

Actalent is seeking a Change Control Specialist External Supply for a fully remote, day-shift role. You will own change control records—from initiation to closure—across packaging, lab chemicals, and medical inventory, acting as External Supply representative with cross-functional teams.

You will drive timely closure of quality records from manufacturing sites nationwide, using TrackWise, while ensuring compliance with pharma/medical device quality and regulatory expectations.

Qualifications

  • Experience owning change control records start to finish.
  • Proficiency with change control for packaging, lab chemicals, and medical inventory.
  • Hands-on TrackWise experience for quality records.
  • Experience in pharmaceutical or medical device industry with regulatory familiarity.
  • Ability to work with minimal supervision while driving change controls to completion.
  • Strong organizational skills to manage multiple records and supplier notifications.
  • Effective cross-functional communication representing External Supply.

Responsibilities

  • Own and manage change control records from initiation through closure.
  • Coordinate with cross-functional teams to align on change control actions.
  • Drive timely closure of quality records from manufacturing sites across the network.
  • Assess and implement supplier change notifications and related changes.
  • Manage change controls related to packaging, lab chemicals, and medical inventory.
  • Collaborate with site and network stakeholders for information gathering and impact assessment.
  • Use TrackWise to create, track, update, and close records per procedures.
  • Ensure adherence to pharmaceutical or medical device quality and regulatory expectations.
  • Work independently with minor supervision and prioritize multiple records to meet deadlines.
  • Support sites across time zones with responsive communication.

Skills

Change control ownership
TrackWise usage
Pharma QA
Remote collaboration

Tools

TrackWise

Job description

Actalent is seeking a Change Control Specialist External Supply for a fully remote, day-shift role. You will own change control records—from initiation to closure—across packaging, lab chemicals, and medical inventory, acting as External Supply representative with cross-functional teams.

You will drive timely closure of quality records from manufacturing sites nationwide, using TrackWise, while ensuring compliance with pharma/medical device quality and regulatory expectations.

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