Job Description
Document Control Lead
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Location: San Diego, CA
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Working Pattern: Hybrid
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Employment Type: Permanent
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An innovative and growing life sciences company is seeking a Document Control & Technical Writing Lead to take ownership of its electronic Quality Management System and document control processes.
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This is an excellent opportunity for an experienced Quality Systems or Document Control professional with strong hands-on MasterControl administration experience to become the internal subject matter expert for the platform.
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The Role
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You will take primary ownership of MasterControl and support the ongoing optimization and administration of the company's eQMS. Responsibilities will include managing document workflows, user access, training assignments, electronic records, reporting, and system improvements.
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You will also oversee the full lifecycle of controlled documentation and partner closely with Quality, Engineering, and other cross-functional teams to ensure documentation remains compliant, accurate, traceable, and inspection-ready.
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Additional responsibilities include:
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- Acting as the primary MasterControl administrator and internal SME
- Managing document control workflows and controlled quality records
- Supporting eQMS configuration, validation, testing, and continuous improvement
- Supporting audit and inspection readiness
- Developing QMS metrics, dashboards, and reports
- Training employees on MasterControl and document control processes
- Supporting technical writing of engineering protocols and reports
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What We're Looking For
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- 5+ years of experience in Document Control, Quality Systems, eQMS administration, or Quality Operations
- Strong hands-on experience administering MasterControl
- Background within medical device, biotechnology, pharmaceutical, or another regulated life sciences environment
- Strong understanding of document lifecycle management and QMS processes
- Knowledge of ISO 13485, FDA regulations, 21 CFR Part 11, GMP/GxP, or related quality frameworks
- Experience supporting audits, change control, CAPA, training, or broader quality systems is highly desirable
- Technical writing experience would be a plus
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This role would suit someone looking to take genuine ownership of an eQMS platform and play a key role in improving document control and quality system processes within an innovative organization.
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If interested, please apply or reach out directly for further information.