Advanced Document Control Specialist | cGxP & EQMS

Valid8 Financial, Inc.; Northern, San Diego (KY, CA); Hybrid; USD 76,000 - 92,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Paid holidays

Time off

Job summary

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is seeking a Document Control Specialist II to manage controlled document workflows and ensure inspection-ready records within the eQMS system. This on-site role in San Diego requires collaboration across cross-functional teams and adherence to cGxP standards.

Ideal candidates will have a Bachelor's degree or equivalent, 2+ years in document control, and experience with EDMS/LMS/EQMS, SOP drafting, and audit support.

Qualifications

• Bachelor's degree or a combination of relevant education and applicable job experience.
• Minimum of 2 years of related experience in document control, records management, technical editing, or a related quality function within an FDA-regulated or other cGxP environment.
• Experience working with Electronic Documentation Management Systems (EDMS), Learning Management Systems (LMS), and/or Electronic Quality Management Systems (EQMS)
• Experience drafting or revising SOPs, protocols, forms, work instructions, and reports.
• Experience supporting inspections or audits preferred

Responsibilities

• Administer controlled document processes across the full lifecycle in accordance with cGxP requirements and established procedures.
• Coordinate routing and use judgment within established guidelines to resolve routine workflow, formatting, metadata, and version-control issues.
• Monitor change orders and requests, communicate status and follow-up needs, and elevate exceptions or risks outside established procedures.
• Execute retention and archival activities for physical and electronic records, including storage, retrieval, reconciliation, and disposition support.
• Create and revise part numbers, BOMs, and electronic batch records in ERP and related systems to support data accuracy and compliance.
• Perform quality reviews for accuracy, consistency, completeness, formatting, numbering, and adherence to standards and procedures.
• Maintain controlled binders and current document copies in cleanroom and laboratory areas.
• Retrieve documentation, assemble audit trails, and prepare complete packages for audits, inspections, and other quality reviews.
• Partner cross-functionally to establish user accounts in the electronic quality management system (eQMS) and support releases and training assignments.
• Provide standard guidance to authors and users on document-control practices and the electronic quality management system (eQMS).
• Identify practical process improvements and adapt established methods to improve accuracy, consistency, and workflow efficiency.

Skills

Judgment

Stakeholder support

Independence

Organization & prioritization

Adaptability

Document control knowledge

Technical proficiency

Education

Bachelor's degree

Tools

EDMS

LMS

EQMS

Job description

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is seeking a Document Control Specialist II to manage controlled document workflows and ensure inspection-ready records within the eQMS system. This on-site role in San Diego requires collaboration across cross-functional teams and adherence to cGxP standards.

Ideal candidates will have a Bachelor's degree or equivalent, 2+ years in document control, and experience with EDMS/LMS/EQMS, SOP drafting, and audit support.