Labeling Documentation Specialist

Labeling Documentation Specialist

About the Role

We are seeking a detail-oriented Labeling Documentation Specialist to support product labeling, document control, and change management activities within a regulated medical device environment. In this role, you will be responsible for maintaining labeling documentation, coordinating change orders, managing product data, and ensuring compliance with quality and regulatory requirements.

This position is ideal for someone with experience in document control, quality systems, labeling operations, change control, or regulatory documentation who enjoys working with complex data, cross-functional teams, and continuous improvement initiatives.

Key Responsibilities

• Review, update, and maintain product labeling documentation to ensure accuracy, consistency, and regulatory compliance.
• Coordinate label-related change orders and change requests through electronic document management systems (EDMS).
• Manage document workflows, approvals, revisions, and implementation activities across cross-functional teams.
• Support updates to labels, Bills of Materials (BOMs), batch records, and related controlled documentation.
• Analyze and maintain large datasets using Microsoft Excel, including Pivot Tables, VLOOKUP/XLOOKUP, and data validation tools.
• Upload, maintain, and verify product and labeling information within Oracle OCPLM and related systems.
• Ensure data integrity and alignment between product records, labeling documentation, and quality system requirements.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Documentation, and Labeling teams to support business objectives.
• Identify opportunities to improve documentation processes, standardize label templates, and reduce errors.
• Support compliance initiatives related to FDA regulations, hazard communication, and Quality Management Systems (QMS).
• Participate in Lean and continuous improvement activities to enhance labeling and documentation workflows.
• Track project milestones, provide status updates, and effectively communicate with stakeholders.

Must-Have Qualifications

• Experience supporting document control, change control, or labeling documentation processes within a regulated environment.

• Experience managing documentation workflows through an Electronic Document Management System (EDMS) or Quality Management System (QMS).

• Strong Microsoft Excel skills, including:

• Pivot Tables

• VLOOKUP/XLOOKUP

• Data analysis and data cleansing

• Large dataset management

• Experience coordinating document approvals and change implementation across multiple departments.

• Strong attention to detail and commitment to data accuracy.

• Excellent written and verbal communication skills.

• Ability to manage multiple priorities in a deadline-driven environment.

• Associate degree or equivalent professional experience.

Preferred Qualifications

• Experience within the medical device, pharmaceutical, biotechnology, or other regulated manufacturing industries.
• Experience with Oracle OCPLM, PLM systems, or product data management platforms.
• Experience with MasterControl or similar electronic quality management systems.
• Knowledge of FDA regulations, 21 CFR Part 820, ISO-based Quality Management Systems, and document control best practices.
• Exposure to labeling operations, regulatory documentation, or quality systems.
• Bachelor"s degree in Biology, Biotechnology, Engineering, Life Sciences, or a related field.
• Experience supporting continuous improvement or Lean initiatives.

What Makes Someone Successful in This Role

• Strong document control and change management experience.
• Ability to work accurately with large volumes of product and labeling data.
• Comfortable collaborating across Quality, Regulatory, Manufacturing, and Engineering teams.
• Highly organized with excellent follow-through.
• Proactive problem solver who thrives in a fast-paced environment.

Work Environment

• Location: Carlsbad, CA
• Schedule: Monday-Friday, 8:00 AM-4:30 PM
• Duration: 12-month contract
• Work Setting: Onsite

This role offers valuable exposure to Quality Systems, Regulatory Affairs, Labeling Operations, Manufacturing, and Product Lifecycle Management while working in a highly collaborative and regulated medical device environment.

Job Type & Location

This is a Contract position based out of Carlsbad, CA.

Pay and Benefits

The pay range for this position is $25.00 - $32.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Carlsbad, CA.

Application Deadline

This position is anticipated to close on Nov 11, 2026.

Workplace Type

This is a fully onsite position in Carlsbad,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.