Quality Lab Associate III - Investigations

About the role

This is where your work makes a difference.

Baxter is dedicated to saving and sustaining lives through innovative healthcare solutions. The Quality Lab Associate III - Investigations plays a crucial role in ensuring product safety and quality.

Responsibilities

• Determines scope, product impact, root cause, corrective and/or preventive actions
• Assembles cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
• Fosters collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
• Closes investigations in a timely manner to meet business and compliance needs
• Works with minimal supervision to drive investigations to closure
• Works with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
• Manages investigation and CAPA documentation in TrackWise in compliance with Baxter practices and procedures
• Understands and implements procedures that support implementation of CAPAs
• Presents and defends investigations during regulatory inspections, as required

Requirements

• Bachelor or Master’s degree in science, preferably in Microbiology, with minimum 2 years of experience conducting root cause investigations in the pharmaceutical/medical products industry
• Minimum of 5 years of experience in Quality Operations, Microbiology Laboratory, and/or Quality
• Strong communication and project management skills
• Thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
• Good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
• Strong technical writing skills and ability to put complex thoughts and issues into writing in such a manner that can be understood by the reader
• Ability to interact with, and influence others at various levels in multiple departments
• Knowledge of FDA quality systems regulations
• Working knowledge of TrackWise system

Qualifications

• Detail Oriented
• Continuous Learner
• Courageous
• Collaborative
• Critical Thinker
• Influential

Skills

• Communication and Project Management
• Problem Solving and Troubleshooting
• Technical Writing
• Interpersonal and Influencing Skills
• Understanding of FDA Quality Systems Regulations
• TrackWise System Knowledge

Benefits

• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave

Pay

The estimated base salary for this position is $80,000-$110,000 annually.

Schedule

Details on the schedule are not specified in the job posting.