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QA Specialist III

QA Specialist III

LongeveronMiami, Florida, USA
2 days ago
Job type
  • Full-time
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 Youll 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 youll need

  • Bachelors degree in Life Sciences discipline is required
  • Minimum of 4 years experience with at least 2 years in a Quality Assurance role and application of GMP principles in cell therapy manufacturing is required
  • Working knowledge and method validation experience in Flow Cytometry ELISA / MSD Mammalian Cell Culture PCR and Biochemical assays
  • Working knowledge of current Good Manufacturing Practices (GMPs) 21CFR 210 / 211 / 600s / 1271 USP and ICH guidelines
  • Strong interpersonal written and verbal communication skills; thrives in fast-paced collaborative environments
  • Skilled in problem-solving root cause analysis and making sound decisions with limited or complex data
  • Demonstrates sound judgment in selecting appropriate methods and approaches to achieve results
  • Able to work flexible working hours including evenings and weekends as needed (included in base salary)
  • Able to travel to support external manufacturing and testing activities

    • What we offer

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

  • Medical dental and vision benefits (employee premiums covered at100% & 90% coverage for spouse / family)
  • 401(k) plan with company match
  • Generous paid time off plan and company holidays
  • 2 paid company shutdowns (winter and summer)
  • Employee assistance program
  • Life and supplemental AD&D insurance

    • 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.

  • Ability to remain standing or stationary for extended periods within a cleanroom or lab setting
  • Frequent use of computers and other office and lab productivity tools
  • May need to lift or carry items up to 30 pounds
  • Must be able to wear cleanroom gowning and PPE for extended periods and must p ass cleanroom gowning certification within 90 days of start date
  • Adhere to internal PPE requirements when working in controlled areas

    • 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.

    Required Experience :

    Senior IC

    Key Skills

    Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

    Employment Type : Full-Time

    Experience : years

    Vacancy : 1

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