Advanced Document Control Specialist - cGxP & eQMS Expert

BioSpace; San Diego (CA); On-site; USD 76,000 - 92,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Paid holidays

Wellness programs

Job summary

Aspen Neuroscience, Inc. in San Diego, CA, seeks a Document Control Specialist II to manage controlled documents and records across the organization. On-site role in Torrey Pines with occasional weekend/holiday work. No relocation.

You will administer document workflows, support audits, and collaborate with cross-functional teams to ensure inspection-ready records within the eQMS and related systems. Strong detail orientation is required.

Qualifications

• Bachelor’s degree or equivalent combination of education and experience.
• Minimum 2 years of document control/records management in FDA-regulated or cGxP environment.
• Experience with EDMS, LMS, and/or EQMS systems.
• Experience drafting SOPs, protocols, forms, and reports.
• Experience supporting inspections or audits preferred.

Responsibilities

• Administer controlled document processes across the full lifecycle per cGxP.
• Coordinate routing and resolve routine workflow, formatting, metadata, and version-control issues.
• Monitor change orders, communicate status, and elevate exceptions or risks.
• Execute retention and archival activities for physical and electronic records.
• Create and revise part numbers, BOMs, and electronic batch records in ERP and related systems.
• Perform quality reviews for accuracy, consistency, completeness, formatting, numbering, and adherence to standards.
• Maintain controlled binders and current document copies in cleanroom and laboratory areas.
• Retrieve documentation, assemble audit trails, and prepare complete packages for audits and inspections.
• Partner cross-functionally to establish user accounts in the eQMS and support releases and training.
• Provide standard guidance to authors and users on document-control practices and the eQMS.
• Identify process improvements to enhance accuracy, consistency, and workflow efficiency.

Skills

Judgment

Stakeholder support

Independence

Organization

Adaptability

Document control

MS Office

Technical writing

Attention to detail

Communication

Continuous improvement

Confidentiality

Education

Bachelor's degree or equivalent

Tools

EDMS

LMS

EQMS

Microsoft Word

Excel

PowerPoint

Adobe Acrobat Pro

Job description

Aspen Neuroscience, Inc. in San Diego, CA, seeks a Document Control Specialist II to manage controlled documents and records across the organization. On-site role in Torrey Pines with occasional weekend/holiday work. No relocation.

You will administer document workflows, support audits, and collaborate with cross-functional teams to ensure inspection-ready records within the eQMS and related systems. Strong detail orientation is required.