CAPA Assoc II
- Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review. (High CA only).
- 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 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.
- 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.
Qualifications for this role
- 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.
Education & Experience
Bachelor's degree (in science or engineering preferred) or equivalent experience.
2+ years of experience in Quality, Manufacturing, Engineering or related field
A Career that Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
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.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.