Quality Assurance Associate I – Document Control

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.

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.

📚 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 Have (not required):
• Experience in aseptic processing or cell therapy environments
• Exposure to Veeva Vault or similar [JA1] EQMS

Work Environment / Physical Demands:
• Must be able to sit and stand for extended periods
• Must be able to lift/carry reports and materials up to 40 pounds, move about the office, communicate efficiently and effectively on the telephone or in person, and complete required paperwork

Why Capricor?
Capricor Therapeutics, a trailblazer in cell and exosome therapy, is dedicated to redefining standards of care with innovative treatments rooted in scientific excellence. Guided by integrity and a passion for patient-centered impact, our team is shaping a brighter future for healthcare. Join us and contribute to a mission-driven group that’s transforming lives with every breakthrough.

Come Work With Us!
At Capricor, you’ll thrive in a collaborative environment that nurtures your professional growth and innovation. Join a dedicated team fueled by a passion for advancing medical science and transforming patient lives through our cutting-edge therapies.

Please note that Capricor does not use Skype for interviews or recruiting activities. Candidates will only be contacted by an official Capricor email address which is @capricor.com. Additionally, Capricor will never ask potential employees to send a check or money to the Company for any reason.

Notice to Recruiting Agencies
Capricor Therapeutics does not accept candidate submissions or referrals from recruiting agencies, staffing firms, or third-party recruiters without expressed consent from Talent Acquisition management and a prior written agreement. Agencies that contact hiring managers directly, solicit business, or submit candidates without this approval will not be considered for any engagement. All such submissions become the property of Capricor Therapeutics, and no fees will be paid for any candidates hired as a result. We appreciate your cooperation and respect for this policy.