Quality Assurance Associate I – Document Control

Capricor Therapeutics•San Diego, CA

2d•$65,000 - $75,000•Onsite

About The Position

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation is Deramiocel ( CAP-1002 ), our lead cell therapy in late-stage development for Duchenne muscular dystrophy. We are also harnessing our proprietary StealthX™ exosome platform to unlock new possibilities in targeted delivery and vaccinology. Every program reflects our commitment to pushing the boundaries of science and delivering life-changing treatments to patients and families who need them most. We are seeking a highly organized, meticulous self-starter who loves bringing order to records and ensuring every document is perfect, on time, and inspection-ready. This dedicated Document Control role will spend the vast majority of the day issuing, tracking, reconciling, filing, and archiving the controlled records that keep our clinical manufacturing running smoothly and compliantly. This position is located at Capricor’s headquarters in San Diego, CA.

Requirements

Bachelor’s Degree (life sciences preferred) and 1–3 years of document control or records management experience in a cGMP environment (strong internships or co-ops considered)
Solid knowledge of Good Documentation Practices (GDP) and basic document control processes in an FDA-regulated environment
Precise attention to detail with outstanding organizational and record-keeping skills
Strong computer skills in MS Word, Excel, Adobe Acrobat; experience with SharePoint or basic electronic systems a plus
Familiar with controlled records management in a cGMP environment
Excellent follow-through and ability to manage multiple concurrent tasks and deadlines
Results-oriented with dedication to accuracy and compliance
Strong initiative and comfortable working in a fast-paced, dynamic environment
Ability to gown and enter classified areas as required to deliver/retrieve records

Nice To Haves

Experience in aseptic processing or cell therapy environments
Exposure to Veeva Vault or similar [JA1] EQMS

Responsibilities

Coordinate, track, issue, reconcile, and archive controlled records including executed batch records, logbooks, QC test records, validation documents, labels, forms, training records, equipment calibration/preventive maintenance records, deviation/CAPA documentation, and audit files.
Issue blank controlled batch records, logbooks, labels, and forms to Manufacturing and QC; receive, review for completeness, and file executed versions.
Scan, upload, index, and maintain electronic records; organize and retrieve physical archives to ensure immediate availability for audits and inspections.
Track document change controls, periodic reviews, training requirements, and record retention schedules; follow up to keep all activities current.
Remove and destroy obsolete documents/records from all points of use.
Generate and maintain document control trackers, overdue lists, and status reports.
Occasionally draft, format, or revise document-control-specific procedures, forms, and work instructions.
Provide rapid, accurate record retrieval and document packages during internal audits, vendor audits, and regulatory inspections.
Support batch record review, label issuance, and basic raw material receipt/documentation as needed.
Other duties as assigned in direct support of document control and records management.