What are the responsibilities and job description for the Associate I, CAPA Writer position at BAXTER?
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.
Summary:
The CAPA I will be an Investigation Owner and/or CAPA Owner and is responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation. The CAPA I will likely assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).
Essential Duties and Responsibilities:
Develop the Investigation Plan and present the Investigation Plan and results at CAPA Review Board.
Determine the scope of the investigation. Assume ownership and lead the Investigation phase of a nonconformance.
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.
Ensure investigation follows the NCR/SNCR procedure, including all data entry and attachment requirements.
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.
Identify any necessary Mitigations to ensure compliance moving forward.
Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities.
Sustain a clean and safe work area using 6S principles
Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP)
Physical Requirements:
Use of hands and fingers to manipulate office equipment is required.
Position requires sitting for extended periods of time.
Duties may require overtime work.
Skill Requirements:
Strong analytical and problem-solving skills.
Good communication and leadership skills.
Good interpersonal/communication/influencing/negotiation skills.
Good project management skills.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.
Education and/or years of experience:
High School diploma or GED
2-4 years of experience in a manufacturing environment regulated by agencies (FDA, Health Canada, EMEA).
Preferred:
BS Preferred.
Trackwise experience preferred
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 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.
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Reasonable Accommodations
Baxter 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 link here and let us know the nature of your request along with your contact information.
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