This is whereyour work makes a difference.
This is where your creativity addresses challenges
We are seeking a Quality Associate II to serve as a Subject Matter Expert (SME) for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics. The ideal candidate will ensure compliance with all applicable processes, systems, and provisions of the Quality System in these areas, identify and resolve possible regulatory and quality risks, and provide Quality support and oversight of areas that input information into these systems.
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 will be doing
Serve as an SME for trending, Management Review, local and corporate metrics, APQR, and other systems involving metrics.
Complete trending, APQR, and Management review process objectives.
Utilize knowledge of software to compile and interpret data, and work with statistical and trending software to analyze data.
Ensure compliance with all applicable SME-related Standard Operating Procedures (SOPs).
Participate in FDA inspections, preparing materials and interfacing directly with FDA.
Ensure audit readiness of the area by researching background information, maintaining current and in alignment with procedures, and reviewing related audit results.
Remain current in industry and regulatory trends in this SME area through attendance at related conferences, seminars, meetings, and other training methods.
Participate in the development and delivery of GxP training programs, as needed.
Work closely with production supervisors, quality, engineering, and other internal groups to accomplish the above and influence necessary actions.
Write, review, analyze, and revise written Standard Operating Procedures (SOPs) to meet regulatory, corporate, and plant requirements.
Support and participate with management during external inspections, as needed.
Maintain a clean and safe work area using 6S principles.
Perform other duties, tasks, or projects, as assigned.
What you will bring
High School Diploma, GED, or equivalent required. Must be at least 18 years of age.
BS in engineering/science or equivalent work experience.
Multiple years of experience in Quality with a medical device/Pharma company or other similarly regulated industry.
Strong interpersonal skills and great attention to detail are necessary.
Must be a strong team player with good problem solving, and good verbal and written communication skills.
Must have the ability to manage people, encourage teamwork and drive decisions.
Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.
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. Overtime is worked as required.
We understand compensation is an important factor as you consider the next step in your career. At Baxter,we arecommitted toequitablepay for all employees, and we strive to be moretransparentwith our pay practices. The estimated base salary for this position is $88,000-$121,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
#LI-EB1
