Quality Lab Associate III - Investigations

Baxter International • Marion, NC

92d • $80,000 - $110,000

About The Position

This is where your creativity addresses challenges. 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.

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.

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.

What This Job Offers

• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree