Quality Associate III - Process Validation

Company: BAXTER
Location: Darien Center
Posted on: May 15, 2022

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. -Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. -Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. -ESSENTIAL FUNCTIONS:

• This position has primary responsibility for driving overall quality performance throughout the supply chain.
• With minimal guidance, schedules and leads a team through the planning and execution of project(s) or defined piece of a larger project. This includes constructing detailed, accurate project schedules, interfacing with development groups and technical support groups.
• Develop and execute IQ, OQ and PQ protocols for product, processes and equipment within the facility.
• Write reports summarizing results and statistics for all equipment, product, or process validation projects.
• Review existing validation reports and identify gaps for GMP compliance. Develop strategies and plans to close the gaps in an efficient and technical manner.
• Participate as an active member in the new products development team and be the Subject Matter Expert of verification and validation activities.
• Conduct or lead corrective and preventive actions in manufacturing using formal problem solving tools and documentation.
• Provide day-to-day support to engineering and manufacturing for verification, validation, design control, test method validation and design transfer activities.
• Mentor others and provides guidance and technical expertise of regulatory and Baxter requirements in validation strategies and processes.
• Assess impact of changes to current Good Manufacturing Practices (cGMP) equipment and systems.
• Review and/or approve documentation as required (Project Plans, Validation protocols, standard operating procedures, etc).
• Conduct process and component validations as applicable.
• Guide peers in the use of statistically-based Quality Engineering approaches in project and test planning and in the analysis and interpretation of test results (e.g. FMEA, DOE, SPC, etc.).
• Supervises/coordinates an engineer and/or technicians on assigned work (as applicable).
• Support or lead failure investigations and root cause analyses relative to validation failures.
• Devises new approaches to complex problems through adaptations and modifications of standard technical principles.
• Ability to prioritize multiple tasks.
• Perform other duties as assignedQUALIFICATIONS, KNOWLEDGE AND SKILLS (PREFERRED):
  • Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Experience in manufacturing/quality Engineering in an FDA regulated environment.
  • Knowledge and working application of FDA cGMP; ANSI/ISO/ASQC; CMDAS requirements.
  • Computer competency in Word, Excel, Power Point, Minitab, Access and databases.
  • Practical experience in manufacturing, test equipment, inspection & Statistical analysis techniques.
  • Desired experience in the medical device industry development and deployment of
  • Quality System, Process Controls & Continuous Improvement Methods (QSR, ISO13485).
  • Desired CQE, CSSBB, CQA or initiative to complete certifications.
  • Ability to multi-task and methodically manage projects.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Effectively operate in and facilitate cross-functional teams with guidance.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.
  • Demonstrated strong analytical problem solving (CAPA), teaming, and communications/interpersonal skills.EDUCATION/EXPERIENCE REQUIRED:
    • Bachelor's degree in science or engineering; advanced degree in the life sciences, physical sciences or engineering, with Ph.D. is ideal.
    • Minimum of 3 - 5+ years related quality engineering/validation experience preferred.
    • American Society of Quality (e.g., CQE, CMQ/OE, etc.) and/or Six Sigma certification preferred.
    • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, TcU, Trackwise, etc.)PHYSICAL DEMANDS:
      • Able to exert up to 10 pounds of force occasionally.
      • Able to sit, stand, walk throughout the work day.WORK ENVIRONMENT:
        • Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
        • Baxter is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture. Some of those work rules include but are not limited to:
        • Wearing a static protective smock at all times while in the work area
        • Working in close proximity to other employees.
        • Working in an environment that is temperature and humidity controlled.#IND-USOPS#LI-BAXGENEqual Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. 037476

Keywords: BAXTER, Buffalo , Quality Associate III - Process Validation, Other , Darien Center, New York