Document Control Specialist

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R; Santa Clarita (CA); On-site; USD 48,000 - 52,000; Full time

Job summary

huMannity Medtec in Santa Clarita, CA is seeking a Document Control Specialist to join our Quality Assurance team. You will administer and maintain controlled documents, records, training documentation, and document control systems in compliance with company requirements and quality standards.

The ideal candidate thrives in a fast-paced environment, collaborates across Engineering, Manufacturing, Quality, and R&D, and has a strong understanding of document control in regulated industries.

Qualifications

• 3+ years in document control or quality systems in regulated environments.
• Strong attention to detail and accuracy.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Visio).
• Experience with electronic document management systems.
• Experience with ERP systems.
• Able to review technical drawings and specifications for compliance.
• Excellent organizational and communication skills.
• Ability to work independently and manage multiple priorities.

Responsibilities

• Manage controlled documents, records, and document control systems in accordance with company procedures and quality requirements.
• Review documents for completeness, accuracy, formatting, and compliance with established standards.
• Edit documents to correct formatting, grammar, typographical, and data inconsistencies.
• Process document change requests and create change orders in a timely manner.
• Coordinate with Engineering, Manufacturing, Quality, and R&D teams to ensure timely completion of document changes.
• Monitor document workflows and follow up on outstanding actions.
• Maintain document logs and records to ensure data integrity and traceability.
• Participate in Change Control Board (CCB) meetings and support change management activities.
• Conduct periodic document reviews and ensure compliance with review schedules.
• Compile metrics, generate reports, and maintain document control KPIs.
• Assign training requirements and ensure training completion by the appropriate personnel.
• Maintain training records and training matrices.
• Monitor overdue training activities and send reminders as needed.
• Enter released parts, fixtures, and assemblies into the inventory management system.
• Issue, audit, and archive laboratory notebooks.
• Update and maintain SOPs related to document control and training.
• Serve as a subject matter expert for document control and training processes.
• Maintain records in accordance with company record retention requirements.
• Support other Quality Assurance activities as assigned.

Skills

Attention to detail

MS Office

eDMS

ERP systems

Documentation review

Independent worker

Communication skills

Tools

ERP systems

eDMS

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Document Control Specialist

Santa Clarita, CA, US

2 days ago Requisition ID: 1053

Salary Range: $35.00 To $38.00 Hourly

We’re growing, and we’re looking for people who want to make an impact.

At huMannity Medtec, innovation starts with people.

For over four decades, our team has been creating technologies designed to improve patient lives. Every person across our organization plays an important role in advancing our mission, whether developing solutions, supporting operations, advancing research, or helping our teams succeed.

We know great work happens when people have the time and space to thrive. That is why we offer a 9/80 schedule, giving employees every other Friday off and 26 long weekends throughout the year. It is one of the many ways we support balance, flexibility, and a workplace where people can do their best work.

What can you expect when you join us?

• A mission you can feel proud of
• A schedule designed with work-life balance in mind
• Challenging work that inspires creativity
• A team that values collaboration and connection
• Weekly team traditions, monthly lunches, and quarterly events that bring us together

We believe great ideas come from supported, engaged, and connected teams.

Position Summary

We are seeking an experienced and detail-oriented Document Control Specialist to join our Quality Assurance team. In this role, you will be responsible for administering and maintaining controlled documents, records, training documentation, and document control systems in compliance with company requirements and quality standards.

The ideal candidate thrives in a fast-paced environment, enjoys working cross-functionally, and has a strong understanding of document control processes within a regulated industry.

What You’ll Do

• Manage controlled documents, records, and document control systems in accordance with company procedures and quality requirements.
• Review documents for completeness, accuracy, formatting, and compliance with established standards.
• Edit documents to correct formatting, grammar, typographical, and data inconsistencies.
• Process document change requests and create change orders in a timely manner.
• Coordinate with Engineering, Manufacturing, Quality, and R&D teams to ensure the timely completion of document changes.
• Monitor document workflows and follow up on outstanding actions.
• Maintain document logs and records to ensure data integrity and traceability.
• Participate in Change Control Board (CCB) meetings and support change management activities.
• Conduct periodic document reviews and ensure compliance with review schedules.
• Compile metrics, generate reports, and maintain document control key performance indicators.
• Assign training requirements and ensure training completion by the appropriate personnel.
• Maintain training records and training matrices.
• Monitor overdue training activities and send reminders as needed.
• Enter released parts, fixtures, and assemblies into the inventory management system.
• Issue, audit, and archive laboratory notebooks.
• Update and maintain Standard Operating Procedures (SOPs) related to document control and training.
• Serve as a subject matter expert for document control and training processes.
• Maintain records in accordance with company record retention requirements.
• Support other Quality Assurance activities as assigned.

What We’re Looking For

Required Qualifications

• 3+ years of experience in document control, quality systems, or a related role within the medical device industry or another regulated environment.
• Strong attention to detail and commitment to accuracy.
• Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Visio.
• Advanced document editing and formatting experience.
• Experience working with electronic document management systems (eDMS).
• Experience using ERP systems.
• Ability to review drawings, procedures, specifications, and other technical documents for compliance with document control requirements.
• Ability to support employees in creating documentation in accordance with established procedures and templates.
• Strong organizational, communication, and problem-solving skills.
• Ability to manage multiple priorities and work independently.
• Willingness to assist with broader Quality Assurance activities.

Preferred Qualifications

• Experience with ISO 13485 and/or ISO 9001 quality management systems.
• Experience supporting change control processes in a regulated manufacturing environment.
• Experience maintaining training records and training management systems.