Summary:
Provides leadership and technical oversight for the QC Microbiology Laboratory supporting aseptic manufacturing operations. Responsible for supervising environmental monitoring, bioburden, bacterial endotoxin, sterility, and water testing activities while ensuring compliance with cGMP, FDA, USP, and regulatory requirements. Leads investigation activities, supports regulatory inspections and customer audits, and ensures laboratory operations maintain a state of inspection readiness.
Essential Duties and Responsibilities:
- Provide microbiological oversight and support 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 escalate 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 escalate 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.
Qualifications:
- Must not be allergic to Penicillin and Cephalosporin or their related product and/or materials.
- Must possess excellent supervisory and interpersonal skills and be able 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 principles, 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 effectively communicate findings to cross-functional stakeholders.
- Ability to lift up to 50 pounds when required.
- Occasional off-shift and holiday work required.
Education and/or Experience:
- 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.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 - $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site:
