Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.
The Document Control Specialist is responsible for maintaining Document Control & Employee Training processes to meet regulatory, quality and company requirements for documentation in a medical device design and manufacturing environment. Provide continuous and rigorous assessment of Quality activities and documentation to assure compliance with the CAPA process, FDA regulations and ISO 13485.
Key Responsibilities
- Interface daily with internal customers (engineers, operations, contract manufacturers) and performs day-to-day Document Control activities processing Change Request and/or Change Order by thoroughly reviewing for accuracy, completeness and adherence to the change control policies and procedures.
- Examine and expedite the progress of documentation within the electronic system.
- Provide status reports on system in-process and released workflows, turnaround time and other metrics as required by manager.
- Support facilitation of Impact Assessments in conjunction with Change Requests and Change Orders
- Assist in records management project scanning, filing, categorization of files and uploading files into the PLM system and create reports as requested.
- Perform duties in support of established records management procedures, including scanning, filing and managing records for storage and retrieval as needed.
- Assist in the preparation of document control metrics and creation of Training Plans, reports and metrics.
- Provide support for regulatory inspections as requested.
- Flexibility and willingness to work outside of normal business hours if requested.
- Maintains accurate records/documentation related to quality system
- Be punctual and adhere to company policies. Meets attendance requirements established by Manager.
- Works in accordance with current Good Documentation Practices (cGDP).
- Volunteers for cross-training and additional responsibilities. Attempts self-improvement that meets company needs through available classes/ seminars.
- Maintains productive work relationships with personnel at all levels. By establishing forward thinking, adaptability, sound decision-making skills, accountability, and keen attention to detail. When a conflict arise the employee deal with this in a constructive and respectful manner.
- Other duties as assigned by manager.
Key Requirements
Education and Training: Bachelor's degree preferred.
Skills and Experience: 5+ years' experience document control, project management or similar detailed orientated work experience. Arena or other Product Lifecycle Management experience and Training or Learning Management System experience.
Position Reports To: Associate Director, Configuration Management and Document Control
This role pays between $75,000 and $85,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
