Document Control Specialist

The Position:

The Document Control Specialist is responsible for the administration of the company’s electronic Quality management systems (eQMS), including platforms such as MediaLab, Simploud, and other digital quality tools. This role supports both CLIA and IVD operations, ensuring regulatory compliance and enabling efficient quality processes across the organization. This role will rely heavily on effective communication, creative solutions, thorough documentation, and timely delivery.

This role can either be hybrid out of our San Diego or South San Francisco offices or may be remote.

Essential Duties and Responsibilities include the following:

•  Administer the organization’s electronic eQMS systems (MediaLab and Simploud).
•  Manage eQMS user profiles and training matrices for different modules within systems.
•  Support all activities related to Document Control in CLIA Laboratories.
•  Manage document life cycle- number assignment, creation or editing of the document, routing, supporting document creation, and document retirement.
•  Manage record retention per company policies.
•  Maintain quality metrics and KPIs; prepare management reports.
•  Train staff members in the use of the eQMS systems for editing, approving, and training on documents.
•  Participate in internal audits to ensure processes comply with established procedures, support audits by external parties.
•  Performs other duties as assigned.

Who You Are:

•  Bachelor’s Degree with a minimum of 5 years relevant experience or Associate Degree with 5+ years’ experience preferred
•  Two or more years of document control experience in a regulated industry as a minimum
•  Strong computer skills, including the use of Microsoft Office applications, such as word processing and spreadsheet software applications
•  Good grammar and spelling skills are required, technical writing experience preferred
•  Experience using an electronic Quality Management System preferred
•  Experience in a clinical testing laboratory environment performing document control duties such as SOP and protocol writing or review, record and data review
•  Be the subject matter expert to train others on document control duties and other eQMS functions with
•  Participate in internal audits as needed
•  Be familiar with CLIA, CAP, New York, and/or FDA/IVD requirements 
•  Detail oriented, strong written and verbal communication skills; ability to communicate effectively when giving and taking information in writing, in person, and over the phone
•  Ability to take initiative and prioritize tasks; good time-management, problem prevention, and problem-solving skills
•  Ability to work independently, within prescribed guidelines, or as a team member

#LI-Onsite, #LI-Hybrid, or #LI-Remote

For candidates based in our San Diego office, the salary range is $86,000- $95,000

For candidates based in our South San Francisco office, the salary range is $95,000 - $105,000.

For candidates working remote (US), the salary range is $83,000 - $94,000.