Document Control Specialist II

Aspen Neuroscience • San Diego, CA

3d • $75,600 - $92,400 • Onsite

About The Position

The Document Control Specialist II supports compliant document and records management across the organization. Working with minimal guidance on routine activities, this role administers controlled document workflows, applies established document control requirements, evaluates moderately complex issues, and partners with cross-functional teams to maintain accurate, current, and inspection-ready records within the eQMS and related business systems. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

Requirements

• 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.
• Ability to exercise sound judgment, evaluate relevant factors, and determine appropriate actions within established guidelines.
• Ability to build productive working relationships and provide clear guidance and support to internal stakeholders.
• Ability to work independently on routine assignments while managing new projects and priorities under general direction.
• Ability to manage multiple priorities, maintain accuracy, and consistently meet deadlines and commitments.
• Ability to succeed in a fast-paced, changing environment while maintaining quality, compliance, and attention to detail.
• Working knowledge of document control and records management principles, including document lifecycle management, revision control, traceability, retention, and archival requirements.
• Advanced proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat Pro for document creation, formatting, editing, and management.
• Ability to proofread and edit complex documents and identify formatting, numbering, structural, and content discrepancies.
• Strong attention to detail with a focus on accuracy, consistency, and quality of work products.
• Effective written, verbal, and interpersonal communication skills with the ability to convey information clearly and professionally.
• Commitment to continuous learning, process improvement, and knowledge sharing.
• Ability to manage sensitive information with discretion and maintain a high level of confidentiality.

Nice To Haves

• 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 escalate 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.

Benefits

• Medical/Dental insurance benefits
• onsite gym
• other wellness perks
• time-off in addition to Company observed holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level