Your role at Baxter:The MO Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence. The Investigator partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs. Interacts with all levels of staff and provides timely updates on investigation status. Manages several investigations at a time.
Your Team at BaxterWithin 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- Determines scope, product impact, root cause, corrective and/or preventive actions
- Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
- Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
- Closes investigations in a timely manner to meet business and compliance needs
- Works with minimal supervision to drive investigations to closure
- Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
- Manages investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
- Understands and implements procedures that support implementation of CAPAs
- Presents and defends investigations during regulatory inspections, as required
What you'll bring- Bachelor or Master's degree in science, preferably in Microbiology, with minimum 2 years of experience conducting root cause investigations in the pharmaceutical/medical products industry
- Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality
- Strong communication and project management skills
- Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
- Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
- Must have strong technical writing skills and able to put complex thoughts and issues into writing in such a manner that can be understood by the reader
- Must be able to interact with, and influence others at various levels in multiple departments
- Must have knowledge of FDA quality systems regulations
- Must have working knowledge of TrackWise system
Other Duties as AssignedThis 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 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 $80,000-$110,000 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.
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US Benefits at Baxter (except for Puerto Rico)This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
