Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.
The
Document Control Specialist at Noctrix Health is responsible for ensuring that the Noctrix Health Document Control System is managed in compliance with the company's Standard Operating Procedures (SOPs). This position oversees the management and administration of the Noctrix eQMS Document Control systems to ensure compliance with applicable internal procedures, medical device Good Manufacturing Practices (GMPs), and regulatory requirements.
The role also includes managing and maintaining the Noctrix Health training program related to controlled documents and internal training. Additional responsibilities include providing QA support for change control, document control, training, eQMS validation, audits, and regulatory inspections. This position reports to the Senior Director of Quality Assurance at Noctrix Health.
This hybrid role requires working on-site at our Pleasanton headquarters at least three days per week. Responsibilities: - Serves as the primary Document Control/eQMS administrator
- Works independently and with the QA team to manage and administer effective Document Control systems, ensuring compliance with applicable internal procedures and regulatory requirements
- Collaborates with the QA Director to establish and execute Document Control procedures
- Writes or edits QMS SOPs related to document control, document management, and other QMS areas as needed
- Supports the update, review, and approval of controlled documents, including standard operating procedures, standard test methods, protocols, reports, and technical documents, according to specific approved formats
- Ensures controlled documents conform to applicable procedures and reviews formats for consistency
- Creates and maintains document templates as needed
- Supports the controlled document lifecycle and retention procedures
- Manages the employee training program and conducts periodic reviews of all electronic training files
- Updates training matrices for all GMP employees; creates and maintains electronic employee training files; assists with group training
- Manages the calibration file and coordinates with suppliers for calibration services
- Maintains ISO standards, ensuring they are current and applicable
- Maintains the Supplier Management Program database and tracks due dates for audit reports and supplier reassessments
- Manages records retention and archiving, ensuring adherence to record retention schedules
- Reviews Lot History Records
- Assists with audits and regulatory inspections as needed
- Provides cross-functional support within the QA department as needed
- Performs other QA-related duties as assigned by the QA Director
- Follows Noctrix procedures, policies, and applicable regulations
Requirements: - Associate's degree or equivalent
- 3+ years of experience in document processing/document management in a medical device or pharmaceutical company
- Preferred experience with Arena, Windchill, or Agile document control systems
- Experience in Document Control, CAPA, Change Control, and Training systems
- Strong technical computer skills with proficiency in various programs and web-based applications, including Microsoft Word, Excel, PowerPoint, OneDrive, and Microsoft Teams
- Knowledge of ISO standards, FDA regulations, and industry guidelines, including ISO 13485, 21 CFR 820, and 21 CFR Part 11
- Team player with strong attention to detail
- Strong interpersonal skills with the ability to interact effectively with colleagues at all levels
- Able to adapt effectively to changing priorities
- Ability to work independently on assignments
- Good problem-solving skills
- Must be able to lift up to 20 lbs at a time
- Must be able to sit for prolonged periods while working at a computer
Compensation: - Base Pay: $80,000 to $110,000 per year
