Quality Lab Associate III - Sterility Assurance

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.

Subject Matter Expert on qualifications related to Environmental Monitoring program and Contamination Control from the microbiological standpoint. Responsible for completion of room qualifications of controlled manufacturing areas. Responsible for completion of assessments to determine impact on the microbiological conditions related to manufacturing clean rooms.

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.

• 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

• Author and complete Environmental Monitoring Performance Qualifications (EMPQ) related to the manufacturing clean/classified rooms in compliance with local and regulatory requirements
• Coordinate sampling activities with EM sampling team and manufacturing department as applicable
• Perform Failure Modes and Effects Analysis, as needed
• Prepare and present to management the trend reports related to EMPQ and contamination control activities
• SME of EMPQ and contamination control aspects providing leadership, technical and quality support to manufacturing and during regulatory inspections or site audits
• Understands and assures conformance to regulations
• Works with regulators during regulatory inspections
• Interacts frequently with functional peer group and managers, as appropriate
• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability, and cost improvements
• Sustain a clean and safe work area using 6S principles
• Learn, understand, and apply thorough quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP). Author and revise Standard Operating Procedures as needed.
• Review and approve EMPQ and contamination control procedures, protocols, and reports
• Perform Sterility Assurance Assessments as part of the Change Control Management process
• Assist in establishing response plans to environmental out of limits
• May be asked to lead classroom-based training for new employees and continuous education classes for established employees

• BS degree in Biology or Microbiology
• Five (5) or more years of professional experience in Laboratory, Quality, Manufacturing, or related field is strongly preferred
• Strong understanding of Environmental Monitoring programs, Microbiology concepts and Good Documentation practices is preferred
• Detailed knowledge of applicable procedures, specifications, regulations, and standards
• Strong analytical and problem-solving skills
• Ability to run multiple projects/investigations/priorities
• Good communication and leadership skills
• Good interpersonal/communication/influencing/negotiation skills
• Good project management skills
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
• Strong technical written skills
• Knowledge of Track Wise Quality Management…