What are the responsibilities and job description for the CAPA II Associate position at Baxter?
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.
Your role at Baxter
This is where your creativity addresses challenges
The Investigation Owner is responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation. The IO may also assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including efficiency criteria and timeframe).
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
- Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review.
- Determine the Define/Measure/Analyze elements of the investigation.
- Determine scope of the investigation. Assume ownership and lead the Investigation phase of a CAPA.
- Identify appropriate/cross-functional team members and assemble the Investigation Team.
- Confirm corrections/containment identified based on the investigation results.
- Identify and employ appropriate investigation tools.
- Determine the appropriate data sources to be evaluated for the investigation, and acquire the required data
- Investigate the root cause(s) of the issue.
- Clearly document the investigation results.
- Communicate the investigation results.
- Ensure investigation follows the CAPA procedure, including all data entry requirements per the checklists.
- Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle.
- Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan.
- Document Action Plan.
- Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities
What you'll bring
- Bachelor's degree (in science or engineering preferred) or equivalent experience.
- 2 years of experience in Quality, Manufacturing, Engineering or related field.
- Understand strategies and be able to invent new methods or new avenues of investigation.
- Thorough knowledge of applicable CAPA procedures, specifications, regulations and standards.
- Strong analytical and problem solving skills.
- Good communication and leadership skills.
- Good interpersonal/communication/influencing/negotiation skills.
- Good project management skills.
- Solid understanding of FDA regulations and application of Good Manufacturing Practices.
We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $72,000 - $99,000 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.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Baxter 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Reasonable Accommodations
Baxter 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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our .
