Baxter International Inc.
Quality Lab Associate I - Environmental Monitoring (7pm-7am),
Baxter International Inc., Marion, North Carolina, United States, 28752
Overview
Quality Lab Associate I - Environmental Monitoring (7pm-7am) role at Baxter International Inc. This position 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. 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. Additional Information
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. We understand compensation is an important factor as you consider the next step in your career. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. Individual pay is based on location, skills and expertise, experience, and other relevant factors. 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.
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Quality Lab Associate I - Environmental Monitoring (7pm-7am) role at Baxter International Inc. This position 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. 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. Additional Information
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. We understand compensation is an important factor as you consider the next step in your career. The estimated base salary for this position is $64,000 - $88,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. Individual pay is based on location, skills and expertise, experience, and other relevant factors. 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.
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