CAPA Investigator

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. 

JOB PURPOSE:
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 Investigator Owner may also assist in identifying and execute the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and time frame).
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• 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 and execute 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 obtain the required data
• Investigate the root cause(s) of the issue. Clearly document the investigation results.
• Communicate the investigation results to:
✓ 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.
✓ Execute the Action /CAPA to develop the Action Plan/Effectiveness Plan. Document Action Plan.
✓ Document Effectiveness Plan, including acceptance criteria and time frame/number of opportunities.
• Should be able to work with many investigations/CAPAs, handle multiple tasks at the same time and work within minimum supervision.
• Assure compliance with company procedures, quality and regulatory requirements, and guidance including GLP, QSR, cGMP, USP, and CDR rules, regulations, and guidelines. Serve as a technical expert and interface with others investigators during both internal and external inspections.
• Develop written reports using technical writing skills including but not limited to: initial, impact assessment, executive summaries, process/product background, investigation plans and investigation results in alignment with Non-conformance and CAPA process requirements.
• Prepare and document the CRB “Change Control Board” review regards to CAPA System.
• Coordinate, participate and perform communication, meetings or teleconference with company departments or facilities, as non-conformance required.
• Should be able to work at any shift when its required. Available to extended shifts, weekends, as necessary
• Team worked oriented.
• Should be able to communicate at all Plant levels.
• Perform data input of Investigation and CAPA phases into Trackwise 8 System.
• Provide guidelines to users on Trackwise 8 transactional tasks and workflows.

OTHER QUALIFICATIONS:
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. Working knowledge of FDA regulations and application of Good Manufacturing Practices.