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This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.
Job Responsibility:
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.
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.
Requirements:
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.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Nice to have:
Minimum 1 year experience in Pharmaceutical/Medical Device industry preferred
Knowledge of FDA quality system regulations is preferred.