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 its mission of providing healthcare solutions. The Quality Lab Associate III - Investigations plays a crucial role in ensuring product safety and quality by investigating microbial out-of-limits occurrences in operations.

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 able 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

• Technical Writing
• Problem Solving
• Project Management
• Communication
• Teamwork
• Leadership

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. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Schedule

Not specified