QC Lab Director: Microbiology & Chemistry Operations

Baxter Healthcare; Jayuya (PR); On-site; USD 120,000 - 165,000; Full time

Job summary

Baxter is seeking a QC Manager in Jayuya, Puerto Rico, to lead Microbiology and Chemistry Laboratories, ensuring operations comply with FDA, USP, and cGMPs. You will develop policies, manage validation programs, and oversee change control, investigations, and product stability initiatives.

You will also mentor staff, drive continuous improvement, and coordinate with Manufacturing, Regulatory, and R&D to meet business priorities while maintaining high standards of quality and safety.

Qualifications

• Bachelor's degree in Chemistry or Microbiology.
• 8+ years of experience in Quality Systems within a regulated environment.
• 3+ years of management or supervisory experience in a laboratory setting.
• Experience with wet chemistry and/or microbiology laboratory procedures.
• Root Cause Analysis training and practical experience.
• Working knowledge of applied statistics and statistical tools.
• Strong understanding of FDA regulations, USP standards, cGMPs, laboratory operations, and quality systems.
• Experience with laboratory validation programs, method transfers, and stabil( ity ).

Responsibilities

• Direct and manage all Microbiology and Chemistry Laboratory operations.
• Coordinate laboratory activities with Manufacturing and Supply Chain teams.
• Lead, supervise, train, and develop laboratory personnel.
• Ensure laboratory services are delivered efficiently, cost-effectively, and in compliance with applicable regulations and standards.
• Perform weekly, monthly, and annual reporting as required by site leadership and company procedures.
• Maintain accountability for the Product Stability Program.

Skills

Quality Systems

Leadership

Communication

Root Cause Analysis

Statistics

Bilingual English/Spanish

Change Management

Education

BSc in Chemistry/Microbiology

Job description

Baxter is seeking a QC Manager in Jayuya, Puerto Rico, to lead Microbiology and Chemistry Laboratories, ensuring operations comply with FDA, USP, and cGMPs. You will develop policies, manage validation programs, and oversee change control, investigations, and product stability initiatives.

You will also mentor staff, drive continuous improvement, and coordinate with Manufacturing, Regulatory, and R&D to meet business priorities while maintaining high standards of quality and safety.