Job description
Job Title: Senior Specialist, Quality Document Management & Training
Location: Remote, Hybrid, or Onsite in Boulder, CO
About Our Company
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.
About The Role
The Senior Specialist, Quality Document Management & Training position is responsible and accountable for supporting and managing document control activities including the quality training program at Foresight Diagnostics. This position will oversee all aspects of document management, including the creation, review, approval, distribution, and archival of quality management system documents and records. Reporting to the Senior Director, Clinical Quality, this position will serve as the subject matter expert for all matters related document control as well as management of quality training within the Quality Assurance department and plays a key role in continuous improvement for scalability and growth.
What You Will Do
Document Management
Manage and file all controlled GxP documentation in compliance with internal procedures and policies, as well as applicable regulatory requirements (FDA, ISO, CAP/CLIA).
Ensure document control requirements are met throughout the document lifecycle, including appropriate filing, archival and obsoletion.
Resolves issues found during documentation review (documentation errors, missing information) as directed by the standard operating procedure(s).
Develop and monitor document review and approval workflows, ensuring timely feedback and version control throughout the project lifecycle.
Ensure documentation is appropriate, justified, and properly redlined, with in-process revisions controlled and approved by responsible functional areas according to timelines and established procedures.
Develop, implement, and maintain standardized processes, procedures, and tools for document management including document numbering, revision control, document distribution, and document review management.
Maintain records in accordance with company record retention policies.
Track and coordinate periodic document reviews with department owners to ensure documents remain accurate and up to date.
Manage the delivery of training on the Document Management and Control processes and the use of the Electronic Quality Management System (eQMS).
Support Change Management activities, as needed.
Other duties as assigned.
System Administration
Serves as the eQMS administrator (e.g. maintain user access, assign user privileges/rights/passwords, manage and administer design changes to system workflows).
Contributes to continuous improvement and optimization of system workflows.
As needed, participate in cross-functional initiatives or support other duties as assigned.
Coordination of Training
Assign new training, re-training, and cancellation of training.
Assists QA management and other department leaders with the development of training plans.
Design, implement, and maintain training requirements and curriculums based on job functions.
Run training reports to monitor compliance and for client/audit requests.
Assist with training of new employees on issuance of records.
What You Will Bring
Bachelor’s degree or applicable experience in a Life Sciences discipline.
3+ years of experience in document control or quality systems, preferably in a medical device, IVD, Pharma, or CAP/CLIA clinical diagnostic lab or other regulated industry.
Experience with MasterControl eQMS platform.
Ability to manage multiple priorities in a fast-paced environment.
Proficiency with Microsoft Office suite (Word, Excel) of products and similar tools.
Ability to work independently and in a team environment.
Attention to detail, strong organizational skills, and ability to work with auditors/regulators.
Strong collaboration across departments and within the organization.
Physical and Mental Requirements, Working Conditions
Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
Travel as required to Boulder, CO or other sites to support operations, audits, and regulatory activities.
This position requires periods of full-time, in-person work in Boulder, CO to support operations, audits, and regulatory activities.
Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
Work is performed in an office environment and requires the ability to operate standard office equipment and keyboards. Must have the ability to walk short distances, and/or drive a vehicle to deliver and pick up materials.
This position requires the ability to identify and resolve quality issues.
Compensation and Benefits
This role is hiring at an annual salary of $105,000 - $120,000 and is eligible for bonus and equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
