QA Specialist III

Job Description

Job Description

About Us

Longeveron Inc, a publicly traded (NASDAQ : LGVN), clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions, with our headquarters located in Miami, FL.

Our lead investigational product is laromestrocel, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult rare diseases and conditions associated with aging.

About the Job

We are seeking an experienced QA Specialist III to support cGMP Quality Assurance team.

Reporting to the QA Supervisor, this role provides QA support for GMP Quality Control and Analytical Testing activities. Responsibilities include oversight of critical processes, review of executed GMP documentation, and IOPQ oversight of laboratory equipment. The Specialist will also support assay qualification and validation, preventative maintenance, calibration, and other QA functions as needed.

The role ensures Quality Control systems and procedures remain compliant with regulatory and industry standards, while driving quality improvements and supporting phase-appropriate GMP manufacturing of biological products.

This role is based onsite at our Miami location and typically requires in-office presence five days a week. Relocation assistance is not available.

What You’ll Do

• Provides QA support to and quality oversight of GMP Quality Control operations for the manufacture of drug products used in clinical trials and for commercial use
• Reviews executed batch records and supporting documentation for accuracy, completeness, and compliance with approved procedures; identifies and resolves discrepancies
• Completes and approves the Final Product Certificates of Analysis and Final Product release
• Performs QA review and approval of Master Batch Records, Protocols, Reports, and SOPs
• Provides QA support for validation function, reviewing and approving applicable procedures, policies, plans, protocols & reports
• Reviews deviations, product non-conformities, and GMP investigations for Quality Control to ensure adequate resolution and compliance with current Good Manufacturing Practices (GMPs) with approval authority as designated by QA Management
• Works cross-functionally with Manufacturing, Supply Chain, Project Management, and Quality Control in meeting project deliverables in a compliant and efficient manner

What you'll need

What we offer

At Longeveron, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including :

Physical and Environmental Requirements

This role works in a clinical manufacturing lab and involves routine use of manufacturing equipment following GMP protocols and may include exposure to cryogenic materials and biological agents. This role involves working in a clean room environment that requires the ability to follow gowning procedures and adherence to strict hygiene standards, working with a team of operators, receiving comprehensive training and support from the operations team.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Longeveron Inc will not pay fees to any third-party agency or firm associated with unsolicited resumes.

Longeveron is an equal opportunity employer that is committed to diversity and inclusion in the workplace. At Longeveron, we prohibit harassment of any kind and any form of discrimination including but not limited to discrimination based on race, color, sex, religion, marital status, sexual orientation, national origin, disability, veteran status, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

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