QC Microbiology Lab Supervisor – Aseptic GMP Lead

Baxter International Inc.; Round Lake (IL); Sur place; USD 80 000 - 110 000; Plein temps

Avantages offerts par ce poste

Health insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days

Résumé du poste

Baxter International Inc. is seeking a senior QC Microbiology leader to oversee environmental monitoring, bioburden, endotoxin, sterility, and water testing within aseptic manufacturing.

You will lead investigations, support regulatory inspections, and ensure laboratory readiness while adhering to cGMP, FDA, USP, and QA standards. The role requires strong supervisory skills, deep regulatory knowledge, and experience with LIMS and data-trending tools.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related life science.
• Minimum 5-7 years of QC Microbiology experience in a pharmaceutical, biologics, medical device, or aseptic manufacturing environment.
• Experience supporting environmental monitoring, sterility testing, bioburden testing, endotoxin testing.
• Experience supporting FDA inspections, customer audits, and regulatory compliance activities.
• Strong knowledge of USP and FDA guidance for sterile drug products and aseptic processing.

Responsabilités

• Provide microbiological oversight for aseptic manufacturing operations, including environmental monitoring programs and sterility assurance.
• Communicate goals, expectations, and priorities; collaborate with supervisors and management to align actions.
• Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective actions.
• Ensure ALCOA+ data integrity and electronic records compliance across laboratory activities.
• Lead microbiological investigations involving environmental monitoring excursions, sterility failures, and related nonconformances; apply CAPA processes.
• Assist in audits and inspection readiness; support response development and corrective actions.
• Review and trend microbiological data to identify emerging risks and drive improvements.

Connaissances

Supervisory skills

Interpersonal skills

Communication skills

Regulatory knowledge

FDA guidance knowledge

Audit experience

Data integrity

Environmental monitoring

Sterility testing

CAPA

Formation

Bachelor's degree in Microbiology

Outils

LIMS

Description du poste

Baxter International Inc. is seeking a senior QC Microbiology leader to oversee environmental monitoring, bioburden, endotoxin, sterility, and water testing within aseptic manufacturing.

You will lead investigations, support regulatory inspections, and ensure laboratory readiness while adhering to cGMP, FDA, USP, and QA standards. The role requires strong supervisory skills, deep regulatory knowledge, and experience with LIMS and data-trending tools.