Quality Systems & Testing Lead – GMP Compliance & Lab Oversight

Life Extension; Miami (FL); Hybrid; USD 70,000 - 95,000; Full time

Job summary

Life Extension in Miami seeks a Quality Systems & Testing Specialist to support compliance with 21 CFR 111 by maintaining quality systems and overseeing testing programs that ensure product quality and regulatory requirements. You will coordinate with contract testing laboratories to guarantee timely and accurate testing, reporting, and documentation.

The role includes managing third‑party testing programs, stability testing, OOS/OOT investigations, CAPAs, GDP compliance, data integrity, and

Qualifications

• Bachelor’s degree in Biology, Chemistry, Life Sciences or related field.
• 2+ years in QA, QC, Laboratory Operations, or Quality Systems within regulated industry.
• Knowledge of 21CFR111, GMP, GDP, and data integrity principles.
• Experience reviewing laboratory data, CoAs, and technical reports preferred.

Responsibilities

• Manage third-party testing programs and reporting.
• Coordinate stability testing and trend analysis.
• Review CoAs and testing documentation for compliance.
• Serve as primary contact for contract laboratories.
• Oversee OOS/OOT investigations per SOPs and regulations.
• Prepare CAPAs, SCARs, and investigation reports.
• Ensure GDP, GMP, and data integrity across records.
• Participate in audits and supplier evaluations.
• Maintain controlled quality documentation and records.
• Provide testing documentation for regulators and international markets.

Skills

Communication skills

Documentation

Data integrity

Analytical testing

GDP knowledge

Regulatory knowledge

Education

Bachelor's degree in Biology, Chemistry, Life Sciences or related field

Tools

HPLC

ICP-MS

FTIR

Job description

Life Extension in Miami seeks a Quality Systems & Testing Specialist to support compliance with 21 CFR 111 by maintaining quality systems and overseeing testing programs that ensure product quality and regulatory requirements. You will coordinate with contract testing laboratories to guarantee timely and accurate testing, reporting, and documentation.

The role includes managing third‑party testing programs, stability testing, OOS/OOT investigations, CAPAs, GDP compliance, data integrity, and