Quality Lab Associate I - Environmental Monitoring (12pm-12am)

About the role

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.

Responsibilities

• Supports the environmental monitoring program by performing testing such as surface testing, viable air monitoring, and air total particle counts.
• Conducts routine risk assessments and HEPA filter inspections in clean-rooms.
• Completes all testing, including special project / protocol testing in a timely following local procedures and cGMP regulations.
• Maintains data integrity and ensures compliance with regulatory agencies.
• Operates equipment such as SAS Air Sampler and Climet Particle Counter for the purpose of collecting air/particulate samples.
• Performs surface sample testing using plate and/or swab method.
• Collects water samples throughout the facility on a weekly/monthly basis.
• Performs 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.
• Performs IMD (Instantaneous Microbial Detection) Testing.
• Reviews Environmental Events/Deviations to ensure documentation and testing is complete prior to submitting for approval.
• Develops joint relationships with Quality Operations/Manufacturing/Engineering to initiate corrective actions/work orders when issues are identified on the floor.
• Sustains 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).
• 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 have good interpersonal skills and able to work optimally and efficiently in a team-based environment.
• 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.

Qualifications

• Authorized to work for an employer in the U.S.
• Compensation and benefits package includes medical and dental coverage that starts on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Additional benefits include Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Childcare benefits.

Skills

• Knowledge 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.
• Knowledge of FDA quality system regulations is preferred.

Benefits

• Medical and dental coverage that starts on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Childcare benefits.

Pay

The estimated base salary for this position is $68,000 - $93,500 annually.

Schedule

Overtime is worked as required.

Other Duties as Assigned

Please note 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.