Documentation Specialist

Kelly; Carpinteria (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly in Carpinteria, CA is seeking a detail-oriented Labeling Specialist to support product labeling initiatives in a regulated medical product environment. This role partners closely with Product Development, Regulatory, Quality, and Marketing to develop, revise, and maintain accurate product labels, Instructions for Use (IFUs), labeling specifications, and electronic labeling systems.

The ideal candidate combines strong graphic design and technical documentation skills with a commitment to

Qualifications

• Bachelor's degree in Graphic Design or a related discipline, or equivalent relevant work experience.
• 3-5 years of working knowledge of BarTender and Librarian, Adobe InDesign, Photoshop, Acrobat Pro, Microsoft Office, and SolidWorks in a PC environment.
• Familiarity with SAP or similar enterprise systems.
• Experience working in a regulated environment, preferably medical devices or another quality-controlled industry.
• Familiarity with regulatory and quality standards such as FDA requirements, ISO 13485, and ISO 9001 a plus.
• Strong attention to detail, particularly when reviewing technical information, labeling content, and controlled documentation.
• Excellent written and verbal communication skills.
• Strong organizational, problem-solving, and project management skills.
• Ability to manage multiple assignments, meet deadlines, and work independently with minimal supervision.

Responsibilities

• Lead cross-functional projects to develop, revise, and maintain product labels, Instructions for Use (IFUs), and related labeling materials.
• Create and update label drawings and specifications using SolidWorks.
• Prepare and manage change control documentation, including drawings, overlays, and label data forms, ensuring timely review, approval, and completion.
• Coordinate with translation vendors to obtain quotes and support the layout of translated labeling materials.
• Collaborate with suppliers to obtain and review label proofs and overlays for accuracy and quality.
• Work with design consultants, illustrators, and technical writers to maintain consistent labeling standards and visual presentation.
• Develop Visual Quality Standards and maintain labeling-related Standard Operating Procedures (SOPs).
• Prepare purchase requisitions and coordinate related administrative activities as needed.
• Manage labeling project timelines, competing priorities, and deadlines.
• Apply applicable industry and regulatory requirements to labeling assignments.
• Support product-related training and stay current on new and existing product requirements.
• Troubleshoot the BarTender/SAP interface, including issues involving label printing and First Article Inspections (FAIs).
• Develop subject matter expertise in electronic labeling systems and support system development at other company locations.
• Identify and resolve labeling and documentation issues while maintaining a high level of accuracy and compliance.

Skills

Attention to detail

Communication

Project management

Independent work

Education

Bachelor's degree in Graphic Design or related

Tools

BarTender

Librarian

Adobe InDesign

Photoshop

Acrobat Pro

Microsoft Office

SolidWorks

Job description

Schedule: Monday–Friday, 8:00 AM–5:00 PM

About the Opportunity

We are seeking a detail-oriented and technically skilled Labeling Specialist to support product labeling initiatives in a regulated medical product environment. This role partners closely with Product Development, Regulatory, Quality, and Marketing to develop, revise, and maintain accurate product labels, Instructions for Use (IFUs), labeling specifications, and electronic labeling systems.

The ideal candidate combines strong graphic design and technical documentation skills with a commitment to accuracy, quality, and regulatory compliance. This is an excellent opportunity for someone who enjoys collaborating across departments, managing multiple projects, and improving labeling processes from development through final approval.

Key Responsibilities

• Lead cross-functional projects to develop, revise, and maintain product labels, Instructions for Use (IFUs), and related labeling materials.
• Create and update label drawings and specifications using SolidWorks.
• Prepare and manage change control documentation, including drawings, overlays, and label data forms, ensuring timely review, approval, and completion.
• Coordinate with translation vendors to obtain quotes and support the layout of translated labeling materials.
• Collaborate with suppliers to obtain and review label proofs and overlays for accuracy and quality.
• Work with design consultants, illustrators, and technical writers to maintain consistent labeling standards and visual presentation.
• Develop Visual Quality Standards and maintain labeling-related Standard Operating Procedures (SOPs).
• Prepare purchase requisitions and coordinate related administrative activities as needed.
• Manage labeling project timelines, competing priorities, and deadlines.
• Apply applicable industry and regulatory requirements to labeling assignments.
• Support product-related training and stay current on new and existing product requirements.
• Troubleshoot the BarTender/SAP interface, including issues involving label printing and First Article Inspections (FAIs).
• Develop subject matter expertise in electronic labeling systems and support system development at other company locations.
• Identify and resolve labeling and documentation issues while maintaining a high level of accuracy and compliance.

Required Qualifications

• Bachelor's degree in Graphic Design or a related discipline, or equivalent relevant work experience.
• 3-5 years of working knowledge of BarTender and Librarian, Adobe InDesign, Photoshop, Acrobat Pro, Microsoft Office, and SolidWorks in a PC environment.
• Familiarity with SAP or similar enterprise systems.
• Experience working in a regulated environment, preferably medical devices or another quality-controlled industry.
• Familiarity with regulatory and quality standards such as FDA requirements, ISO 13485, and ISO 9001 a plus.
• Strong attention to detail, particularly when reviewing technical information, labeling content, and controlled documentation.
• Excellent written and verbal communication skills.
• Strong organizational, problem-solving, and project management skills.
• Ability to manage multiple assignments, meet deadlines, and work independently with minimal supervision.