Document Control Specialist
San Diego, CA
Full Time
Mid Level
ABOUT
Want to work for a fast-paced and disruptive company that is working to revolutionize blood testing? Truvian is a healthcare company at the intersection of diagnostics and consumer tech. We are developing an automated, benchtop diagnostic system to provide lab-accurate results in under 30 minutes for a comprehensive suite of health tests. Our proprietary approach, for which we are seeking FDA clearance, is intended to fulfill the promise of delivering accessible and affordable blood testing from one small blood sample, in minutes, in a retail setting or private clinic.
To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can have an adventure every day. Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!
JOB SUMMARY
Truvian is looking for a Document Control Specialist as we enter the next phase of our evolution. In this role, you will be responsible for managing Truvian’s Document Control System, change orders, and change requests. You will be the main point of contact for all functions to help create, locate, and change documents and records in eQMS. Responsible to support and promote quality across all functions. Supporting cross-functional departments to provide quality guidance. Performing investigations and troubleshooting for nonconformances and corrective and preventive actions.
This role will report directly to the Head of Quality and Regulatory.
HERE’S WHY YOU’LL LOVE THIS JOB:
- You'll work with a rock star team of people who are passionate about the work they do and our ability to disrupt healthcare with our innovative products
- You’ll be a key player in the team responsible for the company’s growth and product launch
- You thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
- You’ll have great perks such as: Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K), paid parental leave, flexible PTO, Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks, on site gym and virtual classes, and a farm to table onsite restaurant including a 30% discount
WHAT YOU WILL DO:
The role will be responsible for Document Control System and will interact with cross-functional departments to provide quality guidance. This will require:
- Represent Quality Assurance and interact with cross-functional departments to provide quality guidance.
- Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (e.g., ISO 13485, 21 CFR 820).
- Support the document control management system within the company’s quality system and assist with the implementation of improvements within the electronic systems (eQMS) capabilities.
- Execute documents and change control processes to ensure standardization, accuracy, and completeness of documents prior to release.
- Plan, create, update part and document numbering, support and collaborate with other functions on changes and change request submission through the eQMS.
- Responsible for employee training on Truvian’s Quality System (e.g., assigning training to new hires, monitoring training timeliness, reporting training status, etc.) Take the initiative on any QA related issues with regard to compliance.
- Support the administration of the eQMS (e.g, setting up users, maintaining user lists, point of contact for user issues, etc.)
- Responsible for batch/lot record review and release.
- Responsible for providing data and information to support the quality metrics data reports.
- Own selected QA processes (e.g., Change Orders, Change Requests, and Training), as assigned.
- Proactively identify internal and external continuous improvement opportunities and drive them to the desired state (See it, Own it, Do it).
- Actively participate and contribute to support the creation of appropriate change control, validation, and qualification documentation associated with complex issues.
- Take responsibility for the ongoing maintenance, audit, and continuous improvement of the Quality Management System, to ensure compliance with ISO, IVDD, and FDA requirements.
- Other duties as assigned to support the overall business objectives
The ideal candidate will have extensive experience in:
- Document control process for medical, biotech, pharmaceutical, or IVD industries
- Working knowledge of Arena eQMS Platform
- Knowledge: Working knowledge of cGMP (CFR/ICH), GDP, and applicable international regulations and guidelines. Advanced familiarity with IVD and biotech manufacturing processes and procedures, including acceptance activities, production and process controls, identification and traceability, quality auditing, etc. Experienced in writing procedures, protocols, and reports.
- Drive for quality: They must have a drive to continuously improve processes for improved performance
- Research skills: They also require the ability to gather and generate data, as well as conduct relevant investigations where nonconformities occur
- Achieving impossible timelines through a combination of superior planning, proven assessment of risk, and the ability to inspire and enable others to move fast
- Partnership and collaboration, ensuring relationships are the forefront of our strategy, emphasizing the company and team over personal goals
- Communication, both oral and written, with the ability to communicate frequently, clearly, and timely manner while keeping both internal and external parties aligned to deliver impact at pace
- Problem solving, with very strong analytical skills, which can be utilized to proactively identify and address issues with a solution-oriented approach, with excellent time management skills
SALARY
$73,000 - $85,000 per year
This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary/Hourly offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by internal equity and relevant qualifications.
FLSA
• Exempt
SUPERVISORY ROLE
• No
PHYSICAL DEMANDS AND ABILITIES
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift 10 pounds at a time
If you want to stand out, please include a cover letter
Truvian provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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