Quality Laboratory Leader - Chemistry & Microbiology

Baxter International Inc.; Cleveland (MS); Sur place; USD 136 000 - 170 000; Plein temps

Résumé du poste

Baxter International Inc. is seeking a senior quality leader to coordinate Chemistry and Microbiology laboratories in its U.S. operations. You will manage a team, ensure product quality, and uphold cGMP and regulatory standards across the lab programs.

The role emphasizes strategic oversight, budget adherence, staff development, and cross‑functional collaboration with QA, Lab Services, and regulators to maintain ongoing compliance and timely product releases.

Qualifications

• Bachelor's degree in Science, with a concentration in Biology or Microbiology.
• 10+ years professional experience in Quality, Manufacturing, Engineering, or related.
• 7+ years of experience in a cGMP-regulated industry.
• Experience with environmental monitoring and contamination control programs in a regulated manufacturing environment.
• Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
• Familiarity with regulatory requirements, including USP, FDA, and ISO standards.

Responsabilités

• Coordinate chemistry laboratory activities and process validation.
• Ensure product quality and regulatory conformance.
• Oversee microbiology lab activities and safety.
• Interface with regulators during inspections.
• Lead quality assessments of internal operations and suppliers.
• Identify and drive continuous improvement projects.
• Maintain SOPs and cGMP compliance.

Connaissances

Analytical skills

Problem solving

Leadership

Communication

Interpersonal skills

Project management

Technical writing

Regulatory knowledge

Team supervision

Safety awareness

Formation

B.Sc. in Biology/Microbiology

Description du poste

Baxter International Inc. is seeking a senior quality leader to coordinate Chemistry and Microbiology laboratories in its U.S. operations. You will manage a team, ensure product quality, and uphold cGMP and regulatory standards across the lab programs.

The role emphasizes strategic oversight, budget adherence, staff development, and cross‑functional collaboration with QA, Lab Services, and regulators to maintain ongoing compliance and timely product releases.