Microbiology & Environmental Monitoring Technician I

Baxter International Inc.; Marion (NC); On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

PTO & Holidays

401K match

Employee Stock Purchase Program

Parental leave

Tuition reimbursement

Job summary

Baxter International Inc. in the United States is seeking a microbiology professional to support environmental monitoring and testing in clean-rooms. You will perform surface and air testing, collect water samples, and ensure regulatory compliance.

The role emphasizes data integrity, cGMP adherence, and collaboration with Quality Operations, Manufacturing, and Engineering to address issues and initiate corrective actions.

Qualifications

• B.S. degree in Microbiology, Biology, or related science.
• Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred.
• Strong communication and project management skills.
• Possess knowledge of core manufacturing and support systems.
• Computer literate/knowledge of Microsoft office applications (Word, Excel).
• Must have good interpersonal skills and able to work optimally and efficiently in a team-based environment.
• Proficient in the aseptic use and handling of media plates and swabs for EM sampling.
• Must be a dedicated individual who requires minimal direction.
• Attention to detail and strong organizational skills.
• Must have a basic understanding of laboratory instrumentation.
• Good documentation skills and knowledge of GDPs (Good Documentation Practices).
• Able to manage multiple tasks/priorities in a timely manner.
• Knowledge of aseptic technique and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology.
• Familiarity with LIMS (or equivalent system) and TrackWise.
• Serve as mentor to Quality Lab Technician (QLT) positions.
• Able to communicate optimally with supervisors and peers
• Knowledge of FDA quality system regulations is preferred.

Responsibilities

• Conduct microbiological analyses on raw materials, in-process and finished products.
• Use laboratory instrumentation and computer systems to collect and record data.
• Complete all testing, including special project / protocol testing in a timely following local procedures and cGMP regulations.
• Maintain data integrity and ensure compliance with regulatory agencies.
• Operate equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples.
• Perform surface sample testing using plate and/or swab method.
• Collect water samples throughout the facility on a weekly/monthly basis.
• Perform weekly and monthly HEPA inspections to ensure integrity of HEPA filters in clean-rooms.
• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in clean-rooms.
• Perform IMD (Instantaneous Microbial Detection) Testing.
• Review Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval.
• Develop joint relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor.
• Sustain a clean and safe work environment applying 6S principles.

Skills

Communication skills

Project management

Interpersonal skills

Teamwork

Education

B.S. degree in Microbiology, Biology, or related science

Tools

LIMS

TrackWise

Microsoft Office

Job description

Baxter International Inc. in the United States is seeking a microbiology professional to support environmental monitoring and testing in clean-rooms. You will perform surface and air testing, collect water samples, and ensure regulatory compliance.

The role emphasizes data integrity, cGMP adherence, and collaboration with Quality Operations, Manufacturing, and Engineering to address issues and initiate corrective actions.