Supv, Quality Lab

Baxter•Round Lake, IL

About The Position

Provides leadership and technical oversight for the QC Microbiology Laboratory supporting aseptic manufacturing operations. The supervisor oversees environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing, ensuring compliance with cGMP, FDA, USP, and other regulatory requirements. The role leads investigations, supports regulatory inspections and customer audits, and maintains laboratory inspection readiness. The position trains and develops laboratory personnel, coordinates daily priorities with other supervisors and management, ensures data integrity and timely completion and review of testing, and communicates microbiological risks and recommendations to site leadership. It also supports continuous improvement through data trending, risk assessment, root cause analysis, and CAPA implementation.

Requirements

Must not be allergic to penicillin and cephalosporin or related products or materials.
Excellent supervisory and interpersonal skills, with the ability to communicate with subordinates, peers, and managers.
Strong knowledge of USP <71>, USP <85>, USP <61>/<62>, USP <1116>, Annex 1, and aseptic processing regulatory expectations.
Demonstrated knowledge of current FDA guidance for sterile drug products produced by aseptic processing and applicable global regulatory requirements.
Experience supporting FDA and regulatory inspections.
Knowledge of contamination control, aseptic behavior monitoring, environmental monitoring programs, and sterility assurance systems.
Demonstrated experience with microbiological risk assessments and quality systems investigations.
Proficiency in electronic quality management systems, LIMS, and data trending tools.
Ability to evaluate microbiological risks and communicate findings effectively to cross-functional stakeholders.
Ability to lift up to 50 pounds when required.
Bachelor's degree in Microbiology, Biology, or a 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.
Experience supporting environmental monitoring, sterility, bioburden, endotoxin, and water monitoring programs, as well as microbiological investigations.

Nice To Haves

Minimum 2 years of supervisory or technical leadership experience.
Experience supporting FDA inspections, customer audits, and regulatory compliance activities.

Responsibilities

Provide microbiological oversight and support for aseptic manufacturing operations, including environmental monitoring, contamination control, and process monitoring.
Communicate goals, expectations, and daily priorities; collaborate with supervisors and management and escalate risks.
Train, certify, coach, and develop laboratory personnel; manage performance evaluations and corrective counseling.
Ensure compliance with ALCOA+ principles, data integrity and electronic records requirements, and laboratory procedures.
Ensure timely completion and review of environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing supporting manufacturing and product release.
Ensure personnel recognize, contain, document, and escalate quality deviations and nonconformances promptly.
Lead and approve microbiological investigations, including excursions, failures, contamination events, deviations, and out-of-specification events; ensure scientifically sound product impact and risk assessments.
Use root cause analysis and Quality Risk Management principles to identify causes and implement effective CAPAs.
Assist with implementing quality and regulatory requirements and ensure compliance with procedures and specifications.
Represent the laboratory during FDA, MOH, corporate, customer, and third-party audits.
Support audit preparation, inspection readiness, response development, and corrective-action implementation.
Review and trend microbiological data to identify risks, process shifts, adverse trends, and improvement opportunities.
Communicate microbiological risks and recommendations to site leadership.
Prepare, review, and revise standard operating procedures and specifications.
Ensure equipment maintenance and calibration are performed on schedule.
Maintain inspection readiness through procedure adherence, completed training, timely quality-record closure, and laboratory documentation.

Benefits

Medical and dental coverage starting on day one.
Basic life, accident, short-term and long-term disability, and business travel accident insurance.
Employee Stock Purchase Plan with the ability to purchase company stock at a discount.
401(k) Retirement Savings Plan with employee contributions and company matching.
Flexible Spending Accounts.
Educational assistance programs.
Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
Family and medical leaves of absence.
Paid parental leave.
Commuting benefits.
Employee Discount Program.
Employee Assistance Program.
Childcare benefits.
May be eligible for discretionary bonuses.