QC Lab Leader – Microbiology & Chemistry

Baxter International Inc.; Jayuya (PR); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical and dental coverage

ESPP (Employee Stock Purchase Plan)

401(k) Retirement Savings Plan

Flexible Spending Accounts

Educational assistance

Paid holidays

Paid time off

Parental leave

Commuting benefits

Employee Discount Program

Employee Assistance Program

Childcare benefits

Job summary

Baxter International Inc. in the United States seeks a QC Manager to lead the Microbiology and Chemistry Laboratories, partnering with Manufacturing, Supply Chain, Quality, Regulatory, and R&D to ensure testing activities comply with FDA regulations, USP standards, and cGMPs.

You will develop and implement laboratory policies, oversee validation and method transfers, drive continuous improvement, and train staff in a regulated setting.

Qualifications

• Bachelor’s degree in Chemistry, Microbiology, or a related scientific discipline.
• Minimum of 8 years of experience in Quality Systems within a regulated environment.
• Minimum of 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
• Fully bilingual in English and Spanish.

Responsibilities

• Direct and manage all Microbiology and Chemistry Laboratory operations.
• Coordinate laboratory activities with Manufacturing and Supply Chain teams.
• Lead, supervise, train, and develop exempt and non-exempt 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.
• Establish, implement, and maintain laboratory standard operating procedures and policies.
• Conduct and approve laboratory investigations, including root cause analysis activities.
• Conduct trend analysis, including Annual Product Review data evaluations.
• Ensure all laboratory changes are appropriately managed through the change control system.

Skills

Bilingual: English/Spanish

Education

Bachelor's degree in Chemistry/Microbiology

Job description

Baxter International Inc. in the United States seeks a QC Manager to lead the Microbiology and Chemistry Laboratories, partnering with Manufacturing, Supply Chain, Quality, Regulatory, and R&D to ensure testing activities comply with FDA regulations, USP standards, and cGMPs.

You will develop and implement laboratory policies, oversee validation and method transfers, drive continuous improvement, and train staff in a regulated setting.