Labeling & Documentation Specialist — Change Control

Talentify; 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

Short and long-term disability

Health Spending Account (HSA)

Transportation benefits

Employee Assistance Program

PTO, Vacation or Sick Leave

Job summary

Actalent is seeking a Labeling Documentation Specialist to optimize product-labeling processes, manage change control, and ensure QMS compliance. The role emphasizes data management using Excel and Oracle OCPLM within a regulated life-sciences setting.

Responsibilities include reviewing labeling data, investigating discrepancies, tracking change orders, and coordinating with labeling, quality, regulatory, and manufacturing teams to improve workflows and accuracy.

Qualifications

• 1+ years of data entry or large-data-set Excel experience.
• Strong hands-on proficiency with Microsoft Excel and large data sets.
• Experience in labeling, document control, quality systems, regulatory affairs, or manufacturing operations.
• Ability to learn and navigate multiple business systems to research data and trace SKU relationships.
• Ability to interpret SOP requirements and apply them to labeling and documentation processes.
• Experience with change control and technical documentation.

Responsibilities

• Review, update, and maintain product-label information for accuracy and compliance with QMS.
• Investigate data discrepancies, identify root causes, and implement corrective actions.
• Initiate and track label Change Orders per change-control procedures.
• Consolidate product and SKU data from systems including Oracle OCPLM.
• Use Excel to analyze and validate large data sets related to labeling, BOMs, and components.
• Support BOM, batch records, and label changes and assess impacts.
• Navigate business systems to trace parent/child SKU and component relationships.
• Apply SOP requirements when assessing changes and document technical justifications.
• Write clear technical justifications and present changes for review through change-control processes.
• Collaborate with labeling, documentation, quality, regulatory, and manufacturing teams.
• Identify opportunities to standardize label templates and improve workflows.
• Communicate timelines and progress to stakeholders and ensure alignment.
• Participate in Lean continuous-improvement activities to enhance label-printing processes.
• Operate effectively in a fast-paced environment with minimal supervision.

Skills

Excel data analysis

Data entry

Documentation control

Quality systems

Regulatory compliance

SOP interpretation

Cross-functional collaboration

Attention to detail

Lean / continuous improvement

MS Office

Education

Associates degree

Bachelor's degree in Science/Engineering/Biology or related

Tools

Oracle OCPLM

MasterControl

ERP systems

Job description

Actalent is seeking a Labeling Documentation Specialist to optimize product-labeling processes, manage change control, and ensure QMS compliance. The role emphasizes data management using Excel and Oracle OCPLM within a regulated life-sciences setting.

Responsibilities include reviewing labeling data, investigating discrepancies, tracking change orders, and coordinating with labeling, quality, regulatory, and manufacturing teams to improve workflows and accuracy.