Document Control Specialist

Position Overview:

The
Document Control Specialist
supports the Quality Management System (QMS) for an IVD medical device manufacturing environment. This role manages controlled documents, drives change control activities, supports quality investigations, and maintains essential quality tools such as the Learning Management System (LMS) and calibration program. This is an onsite, detail-oriented position that ensures compliance with FDA and ISO 13485 standards while partnering closely with cross-functional teams.

Company Overview:

Applied BioCode is a pioneering molecular diagnostics company based in Southern California, dedicated to transforming how laboratories detect and diagnose infectious diseases. We design and develop high-throughput multiplex testing platforms powered by our proprietary Barcoded Magnetic Bead technology, enabling labs to run efficient, cost-effective panels for respiratory, gastrointestinal, and infectious disease testing — all in a single workflow. By combining innovative biochemistry, engineering, and automation, we empower healthcare and research labs to deliver faster, more accurate results. At Applied BioCode, you'll join a collaborative team committed to advancing public health through technology and meaningful scientific impact.

Job Duties & Responsibilities:

• Manage the lifecycle of controlled documents including creation, review, routing, approval, issuance, and archival

• Lead change control activities and support implementation and communication of document updates

• Maintain the Document Archive and ensure compliance with retention and accessibility requirements

• Serve as the primary reviewer for QMS documents to confirm accuracy and regulatory alignment

• Update and improve document control SOPs, forms, and process workflows

• Administer and maintain the Learning Management System (LMS) with accurate training assignments and completion tracking

• Provide employee training on document control, QMS processes, and quality system tools

• Support onboarding for new hires on QMS expectations and documentation systems

• Manage equipment calibration scheduling, documentation, and system updates

• Review and approve manufacturing batch records and incoming inspection documentation

• Support nonconformance investigations, CAPAs, deviations, and complaint-related documentation

• Conduct Product History Reviews and prepare trend summaries to support complaint investigations

• Track, analyze, and present quality metrics and documentation trends

• Collaborate cross-functionally and contribute to continuous improvement efforts

• Perform other quality-related duties as assigned

Preferred Qualifications:

• Experience with electronic QMS platforms (ComplianceQuest preferred)

• Prior work in IVD, medical device, biotech, or other FDA-regulated environments

• Experience supporting internal or external audits

• Familiarity with training records, LMS systems, or calibration programs

• Strong documentation, communication, and prioritization skills

Required Qualifications:

• High school diploma required; Bachelor's degree preferred in Life Sciences, Engineering, Quality, or a related technical field.

• 1–5 years of experience in a regulated industry (FDA, ISO 13485, or similar)

• Knowledge of 21 CFR 820 and ISO 13485:2016

• Experience with QMS software or electronic document control systems

• Strong attention to detail, organization, and accuracy

• Proficiency in Microsoft 365 (Word, Excel, PowerPoint, Outlook, Teams, SharePoint)

• Ability to work independently and manage multiple priorities

• Strong communication and interpersonal skills

Work Environment:

• Onsite, Monday thru Friday, role within a regulated IVD/medical device manufacturing environment

• May require lifting up to 20 lbs and extended periods of standing or desk work

• Occasional flexibility in work hours to support urgent document or compliance needs

Benefits:

•
Competitive salary: $65,000–$70,000 annually, DOE (Depends on Experience)

• Medical, dental, and vision insurance

• 401(k) plan with company match

• Paid vacation, holidays, and sick leave

• Opportunities for professional growth within an FDA-regulated environment

• Mission-driven, collaborative culture focused on innovation and continuous improvement

Equal Opportunity Statement:

Applied BioCode, Inc. is an Equal Opportunity Employer.

We are committed to creating an inclusive environment for all employees and applicants. We prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, pregnancy, veteran status, or any other protected characteristic as outlined by federal, state, or local laws. All employment decisions are based on qualifications, merit, and business needs.