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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.
Job Responsibility:
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
Requirements:
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