CAPA Investigator
Baxter
- Jayuya, PR
- Permanent
- Full-time
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 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.
- EDUCATION and/or EXPERIENCE
- LANGUAGE SKILLS
- MATHEMATICAL SKILLS
- REASONING ABILITY
- CERTIFICATES, LICENSES, REGISTRATIONS, EXAMS
- COMPANY REGULATORY COMPLIANCE
- PHYSICAL DEMANDS
- WORK ENVIRONMENT
- SAFETY EQUIPMENT and/or EQUIPMENT
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.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 OpportunityBaxter 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.Reasonable AccommodationsBaxter 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 NoticeBaxter 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 .