Quality Lab Associate III - Investigations

Baxter•Marion, NC

65d•$80,000 - $110,000

About The Position

The MO Investigator leads the investigation of microbial out of limits that occur in operations and is responsible for conducting the investigation, determining root cause, and defining effective corrective and/or preventive actions to prevent recurrence. The Investigator partners with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs. Interacts with all levels of staff and provides timely updates on investigation status. Manages several investigations at a time. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

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
Must have thorough understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC)
Must have 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
Must be able to interact with, and influence others at various levels in multiple departments
Must have knowledge of FDA quality systems regulations
Must have working knowledge of TrackWise system

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

Benefits

Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Flexible Spending Accounts
educational assistance programs
commuting benefits
the Employee Discount Program
the Employee Assistance Program (EAP), and childcare benefits