Quality Lab Associate I - Environmental Monitoring

Responsibilities

• Support the environmental monitoring program by performing microbiological analyses on raw materials, in-process, and finished products
• Conduct surface testing, viable air monitoring, and air total particle counts in clean-room environments
• Operate laboratory instrumentation including SAS Air Samplers and Climet Particle Counters
• Perform weekly and monthly HEPA filter inspections and Real Time Risk Assessments (RTRA) to identify potential contamination
• Collect water samples throughout the facility on a scheduled basis
• Maintain data integrity and ensure compliance with cGMP, GLP, and USP regulations
• Review Environmental Events and Deviations to ensure complete documentation prior to approval
• Collaborate with Manufacturing and Engineering teams to initiate corrective actions when issues are identified

Requirements

• B.S. degree in Microbiology, Biology, or a related science
• Proficiency in aseptic technique and the handling of media plates and swabs
• Strong knowledge of Good Documentation Practices (GDP)
• Familiarity with LIMS and TrackWise
• Ability to work the 7pm-7am shift
• Strong attention to detail and organizational skills
• Proficiency in Microsoft Office applications (Word, Excel)

Preferred Qualifications

• Minimum 1 year of experience in the Pharmaceutical or Medical Device industry
• Knowledge of FDA quality system regulations

Benefits

• Medical, Dental, and Vision coverage starting on day one
• 160 hours of Paid Time Off and Paid Holidays
• 401K match and Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

About the Company

Baxter is a global healthcare leader dedicated to the mission to Save and Sustain Lives. Since 1931, we have been at the forefront of innovation, redefining healthcare delivery to make a greater impact on patients around the world.