Remote Change Control Specialist – External Supply

Actalent; United States; Remote; USD 62,000 - 65,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability coverage

Remote work environment

Job summary

Actalent is seeking a Specialist Manufacturing External Supply for a fully remote day-shift role. You will own and execute change control quality records, coordinating across cross-functional teams to ensure timely closure of records from manufacturing sites nationwide.

You will use TrackWise, focus on packaging, lab chemicals, and medical inventory changes, and operate with minimal supervision while meeting deadlines in a fully remote environment.

Qualifications

• Experience owning change control records end-to-end.
• Proficiency with packaging, lab chemicals, and medical inventory CQs.
• Hands-on TrackWise experience managing quality records.
• Background in pharmaceutical or medical device industries.
• Ability to work with minimal supervision and meet deadlines.
• Strong organization to handle multiple records across sites.
• Effective communication across cross-functional teams.

Responsibilities

• Own and manage change control records from initiation through closure.
• Coordinate change control activities across cross-functional teams.
• Drive timely closure of change control quality records.
• Assess and implement supplier change notifications.
• Manage change controls for packaging, lab chemicals, and medical inventory.
• Gather information with sites to assess impact and execute actions.
• Use TrackWise to create, track, update, and close records.
• Ensure activities adhere to quality and regulatory expectations.
• Work independently with minimal supervision.
• Support sites across time zones with responsive coordination.

Skills

Change control

TrackWise

Cross-functional

Documentation

Pharma/Med devices

Independent work

Tools

TrackWise

Job description

Actalent is seeking a Specialist Manufacturing External Supply for a fully remote day-shift role. You will own and execute change control quality records, coordinating across cross-functional teams to ensure timely closure of records from manufacturing sites nationwide.

You will use TrackWise, focus on packaging, lab chemicals, and medical inventory changes, and operate with minimal supervision while meeting deadlines in a fully remote environment.