Labeling Documentation & Change Specialist

ACTalent; Carlsbad (CA); On-site; USD 34,000 - 44,000; Full time

Benefits offered by this job

Medical, Dental & Vision

401(k) Retirement Plan

Life Insurance

PTO/Time Off

Job summary

Actalent seeks a detail-oriented Labeling Documentation Specialist to support product labeling, document control, and change management in a regulated medical device environment. You will maintain labeling documentation, coordinate change orders, and ensure compliance with quality systems.

You will work with Quality, Regulatory Affairs, Manufacturing, Documentation, and Labeling teams to improve processes and reduce errors, while handling large datasets and ensuring data integrity across

Qualifications

• Experience with document control in a regulated environment.
• Experience with EDMS or QMS for document workflows.
• Strong Excel skills including Pivot Tables, VLOOKUP/XLOOKUP, and data cleansing.
• Ability to manage approvals and changes across multiple departments.
• Excellent written and verbal communication.
• Multitask in a deadline-driven setting.
• Associate degree or equivalent professional experience.

Responsibilities

• Review, update, and maintain product labeling documentation for accuracy and regulatory compliance.
• Coordinate label-related change orders via electronic document management systems.
• Manage document workflows, approvals, revisions, and implementation across cross-functional teams.
• Support updates to labels, BOMs, batch records, and related documentation.
• Analyze large datasets using Excel and data validation tools.
• Upload and verify product and labeling data in Oracle OCPLM and related systems.
• Ensure data integrity between product records and labeling documentation.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Documentation, and Labeling teams.
• Identify opportunities to improve documentation processes and standardize label templates.
• Support FDA regulatory compliance, hazard communication, and QMS initiatives.
• Participate in Lean initiatives to improve labeling workflows.
• Track milestones, communicate status to stakeholders.

Skills

Document control

Change control

EDMS/QMS

Excel pivot tables

VLOOKUP/XLOOKUP

Data analysis

Attention to detail

Communication

Cross-functional collaboration

Education

Associate degree or equivalent

Tools

Oracle OCPLM

PLM systems

MasterControl

Job description

Actalent seeks a detail-oriented Labeling Documentation Specialist to support product labeling, document control, and change management in a regulated medical device environment. You will maintain labeling documentation, coordinate change orders, and ensure compliance with quality systems.

You will work with Quality, Regulatory Affairs, Manufacturing, Documentation, and Labeling teams to improve processes and reduce errors, while handling large datasets and ensuring data integrity across