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Associate I, Capa

3 months ago

Alliston, Canada BAXTER Full time

**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 investigations, identifying the root cause(s) of an event, and documenting the results of the investigation. The CAPA I will assist in identifying the appropriate actions to mitigate or eliminate the root causes, and will determine an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).

**General Expectations**

The top two priorities for all Baxter Alliston employees are Safety and Quality:
**Safety**: Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:

- Following all safety procedures.
- Understanding potential hazards in your area
- Wearing appropriate PPE.
- Reporting all incidents / near-misses / concerns.
- Embracing 6s.

**Quality**: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”. This can be achieved through:

- Following Good Manufacturing Practices (GMP)
- Adhering to all quality procedures.
- Completing training on-time.
- Doing it Right the First Time
- Reporting any quality concerns immediately

As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:

- Participating in improvement activities.
- Identifying and implementing continuous improvement ideas.
- Participating in tier meetings.
- Recognizing your peers.
- Embracing 6s.
- Identifying and implementing VIP’s (Value Improvement Project).
- Embracing continuous learning.
- Utilizing Leader Standard Work.
- Utilizing Root Cause Analysis tools to identify and prevent problems from recurring
- Driving measurable results.

**Major Responsibilities/Activities**
- Develop the Investigation Plan and present the Investigation Plan and results at CAPA Review Board
- Determine the Define/Measure/Analyze elements of the investigation.
- Determine 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

**Qualifications**:
**Education Level**:

- B.S. (Science or Engineering Preferred) with associated experience in GMP Pharmaceuticals, required.

**Major Subjects/Specialties**
- Additional training in Quality Assurance, Quality tools, statistics, qualification/ validation, Six Sigma/ Continuous Improvement tools and medical device/pharmaceutical regulations, required.

**Type of Experience**

Required:

- Experience in medical technology/ pharmaceuticals, or a related regulated environment.
- Experience in undertaking problem solving and use of DMAIC tools.
- Experience with non-conformance investigations and CAPA within a regulated Quality Management System.
- Good attention to detail and ability to demonstrate critical thinking.
- Highly proficient communicator, both verbal and written, and be able to convey complex ideas.
- Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
- Knowledge and experience of cGMP’s in accordance with the applicable regulations.
- Must have basic English written and oral communication skills adequate to communica