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.

 

DUTIES AND 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.

EDUCATION AND EXPERIENCE:

  • 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

 

JOB SPECIFICATIONS:

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

 

 

 

 

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee is frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the ability to perform experiments in the laboratory, and type and use a computer.

 

PHYSICAL DEMANDS

 

While performing the duties of this Job, the employee is regularly required to stand; walk; sit; use hands and finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 10 pounds.

Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

 

EEO and Employment Eligibility:

Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

Total Rewards and Culture:

Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, onsite gym, and other wellness perks.

The anticipated salary range for candidates who will work in San Diego is $75,600 - $92,400 annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc.  Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.