Quality Lab Associate I - Environmental Monitoring (12 hours)

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirá un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, el clínicas y en los hogares. Por más de 85 años hemos sido pioneros en innovaciones médicas significativas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas-donde tu propósito acelera nuestra misión.

Your role at Baxter:

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 cleanrooms.

What you'll be doing:

• Collect environmental monitoring samples throughout the facility following Standard Operating Procedures on a defined frequency
• 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
• Performs weekly and monthly HEPA inspections to ensure integrity of HEPA filters in cleanrooms
• Performs weekly Real Time Risk Assessments (RTRA) to identify potential contamination issues in cleanrooms
• Perform IMD (Instantaneous Microbial Detection) Testing
• Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval
• Fosters collaborative relationships with Quality Operations/ Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor
• Complete testing within required timeframes
• Sustain a clean and safe work environment utilizing 6S principles
• Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise

What you'll bring:

• B.S. degree in Microbiology, Biology, or related science
• 0-2 years of experience; 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 effectively 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 self-driven individual who requires minimal supervision
• 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.
• Must be able to communicate effectively with supervisors and peers.
• Knowledge of FDA quality system regulations is 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 our employees, and we strive to be more transparent with our pay practices.  To that end, this position has a salary range of $64,000 to $88,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position.  The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

US Benefits at Baxter (except for Puerto Rico)

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