Aseptic QC Microbiology Lab Lead

Baxter Healthcare; 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)

Résumé du poste

Baxter is seeking a QC Microbiology Laboratory leader to oversee aseptic manufacturing environmental monitoring, bioburden, endotoxin, sterility and water testing with a focus on cGMP compliance. You will lead investigations, support regulatory inspections and audits, and ensure inspection readiness.

A Bachelor's in Microbiology with 5–7 years of QC microbiology experience and supervisory skills is preferred.

Qualifications

• Bachelor's degree in Microbiology, Biology, or related life science discipline.
• Minimum 5-7 years of QC Microbiology experience in a pharmaceutical, biologics, medical device, or aseptic manufacturing environment supporting environmental monitoring, sterility assurance, and microbiological testing programs.
• Minimum 2 years of supervisory or technical leadership experience preferred.
• Experience supporting environmental monitoring, sterility testing, bioburden testing, endotoxin testing, water monitoring programs, and microbiological investigations.
• Experience supporting FDA inspections, customer audits, and regulatory compliance activities preferred.

Responsabilités

• Provide microbiological oversight for aseptic manufacturing operations, including environmental monitoring programs, contamination control initiatives, and process monitoring activities.
• Provide clear communication regarding goals, expectations, and daily priorities; collaborate with other supervisors and management to ensure alignment and elevate risks.
• Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective counseling in a timely manner.
• Ensure compliance with ALCOA+ principles, data integrity requirements, electronic records requirements, and applicable laboratory procedures.
• Ensure timely completion and review of environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing in support of manufacturing operations and product release.
• Ensure laboratory personnel recognize, contain, document, and expedite quality related deviations or nonconformances in a timely manner.
• Lead and approve microbiological investigations involving environmental monitoring excursions, sterility failures, bioburden excursions, endotoxin results, contamination events, laboratory deviations, and out of specification events while ensuring scientifically sound product impact and risk assessments. Utilize structured root cause analysis tools and Quality Risk Management principles to identify causes and implement effective CAPAs.
• Assist in implementing quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, and USP rules and guidelines) and ensure compliance with standard operating procedures and specifications.
• Act as a primary laboratory representative during FDA, MOH, corporate, customer, and third-party audits. Support audit preparation, inspection readiness activities, response development, and implementation of corrective actions.
• Review and trend microbiological data to identify emerging risks, process shifts, adverse trends, and opportunities for continuous improvement. Communicate microbiological risks and recommendations to site leadership.
• Prepare, review, and revise standard operating procedure and specifications.
• Ensure equipment maintenance and calibration are performed on schedule.
• Ensure laboratory operations remain inspection ready through adherence to procedures, completion of training, timely closure of quality records, and maintenance of laboratory documentation.

Connaissances

Microbiology

Environmental monitoring

Regulatory compliance

Leadership

Data integrity

Root cause analysis

Formation

Bachelor's degree in Microbiology

5-7 years QC Microbiology

Supervisory experience

Outils

LIMS

Data trending tools

Description du poste

Baxter is seeking a QC Microbiology Laboratory leader to oversee aseptic manufacturing environmental monitoring, bioburden, endotoxin, sterility and water testing with a focus on cGMP compliance. You will lead investigations, support regulatory inspections and audits, and ensure inspection readiness.

A Bachelor's in Microbiology with 5–7 years of QC microbiology experience and supervisory skills is preferred.