Quality Lab Associate III - Sterility Assurance

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

This is where your creativity addresses challenges

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.

Your Team at Baxter

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.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What we offer from Day One:

• 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

What you'll be doing

• 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 manages 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 rigorous 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

What you'll bring

• 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 manage 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