Baxter International Inc.
Quality Lab Associate I - Environmental Monitoring (7pm-7am)
Baxter International Inc., Marion, North Carolina, United States, 28752
Quality Lab Associate I - Environmental Monitoring (7pm-7am)
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. Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. What we offer from Day One Medical, Dental and Vision coverage 160 hours of Paid Time Off and Paid Holidays 401K match Employee Stock Purchase Program Paid Parental Leave Tuition Reimbursement What you'll be doing 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. What you'll bring 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. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information. Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
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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. Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts. Responsible for conducting routine risk assessments and HEPA filter inspections in clean-rooms. Your Team at Baxter Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. What we offer from Day One Medical, Dental and Vision coverage 160 hours of Paid Time Off and Paid Holidays 401K match Employee Stock Purchase Program Paid Parental Leave Tuition Reimbursement What you'll be doing 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. What you'll bring 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. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information. Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.
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