CAPA Investigator

Baxter

  • Jayuya, PR
  • Permanent
  • Full-time
  • 18 days ago
This is where you save and sustain livesAt 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.
QUALIFICATIONS:
  • EDUCATION and/or EXPERIENCE
Bachelor’s degree (BS) in Business Administration or Science with three to five years of experience, or Master’s Degree, with 3 years’ experience.
  • LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, internal or external audits and other departments. Fully bilingual (English and Spanish). Ability to communicate, read, write and understand English/Spanish languages.
  • MATHEMATICAL SKILLS
Ability to work with mathematical concepts such as probability and statistical analysis (SPC). Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • REASONING ABILITY
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • CERTIFICATES, LICENSES, REGISTRATIONS, EXAMS
cGMP's Training, and other trainings, certificates, licenses and registrations that the immediate supervisor refers.
  • COMPANY REGULATORY COMPLIANCE
Observe and promote company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.
  • PHYSICAL DEMANDS
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handles or feels reach with hands and arms; and climb or balance. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, and color vision.
  • WORK ENVIRONMENT
While performing the duties of this job, the employee is occasionally exposed to extreme cold. The noise level in the work environment is usually moderate. Should be able to work at any shift when it is required.
  • SAFETY EQUIPMENT and/or EQUIPMENT
While performing the duties of this job, the employee has to use computer, telephone, Company Procedures and Policies, office supplies, copy machine, fax machine, calculator. The incumbent must use the proper equipment inany Baxter area to comply with Company policies and any internal or external regulation or policy (eg. safety shoes, safety glasses, ear plugs, safety gloves, etc.).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.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 .

Baxter