This position is responsible for maintaining and sustaining HealthTell’s change control, training and documentation processes and supporting all related activities in accordance with HealthTell’s processes, 21 CFR Part 820 and ISO-13485. Responsible for creating and maintaining and controlling all quality system records, establishing, upgrading and supervising document control process, standards creation and organization, change order system management and document control system security. Support departments by creating, processing, distributing and controlling revisions of the quality system and related documentation.
HealthTell and PatientsLikeMe are now central parts of iCarbonX's Digital Life Alliance, which is working to combine biological and patient-generated data with artificial intelligence technology to more rapidly detect meaningful signals about health, disease and aging, deliver a personalized guide for living a healthy life, and help industry learn even more about how to improve outcomes, and lives.
This position is based in Chandler, Arizona but is expected to support other company and Alliance partner locations, as needed. Reports to the Director of Quality.
- Manage the change control system; review, route, assess impact and release change orders.
- Maintains and continuously improves document control system and SOP’s per FDA regulation standards requirements.
- Generate/present QA reports as needed and coordinate data for management review
- Monitor status of in-process document changes to ensure timely revisions.
- Able to positively interact with internal and external customers.
- Assist customers with problem solving and offer possible solutions utilizing understanding of the job and applies knowledge and skills to complete a wide range of tasks.
- Support HealthTell during internal/external audits.
- Maintain record integrity by the archiving and retrieving of record
- Manage and maintain external standards.
- Must be able to work independently and lead projects. on .
- Oversee the maintenance of the document management system for Quality Records master drawings, CO’s, Specifications, SOP’s, etc., as required.
- Responsible for Change Control Administration. Reviews CO’s for accuracy, Monitor and follow-up on the status of required action.
- Controls obsolescence of documents
- This position assumes and performs other duties as assigned.
- Bachelor’s degree biology or related field.
- 4+ years of experience in a compliant quality system pharmaceutical or biotech company and experience with both paper and electronic documentation control, training and change control.
- Thorough knowledge of all aspects of training, documentation control and Change processes.
- Aptitude for detail, accuracy and excellent organization skills, knowledge of PC based programs such as: Microsoft Word, MRP system, Excel and data input.
- Ability to identify, and resolve problems, and handle multiple assignments.
- Great and proven communication skills.
- Ability to effectively lead the documentation services function and engage senior management on quality issues
- Strong project management skills with an emphasis on critical thinking and problem solving
- Outstanding written and verbal communication skills
- Ability to coordinate & influence across various parts of the company
- Committed to the values of integrity, accountability, transparency, scientific rigor and drive
HealthTell is a well-funded Life Sciences company that is commercializing the ImmunoSignature™ technology for accurate and timely detection, and monitoring progression of chronic diseases. Based on a robust, scalable, proprietary technology, the company will provide the first and only diagnostic platform capable of detecting the presence of disease, stratifying patients, and monitoring disease progression. The ImmunoSignature™ technology is unlike any other, measuring the immune system instead of relying on inaccurate biomarkers or radiographic images. The ImmunoSignature™ Test will enable physicians to detect disease at an early stage, resulting in improved outcomes and reduced healthcare expenditures.
HealthTell is an equal opportunity employer.