Responsibilities:

Determines scope, product impact, root cause, corrective and/or preventive actions of microbial excursions including surfaces, viable air, non-viable air, water, bioburden and endotoxin testing results
Expeditiously identifies potential root causes for excursions and immediate mitigation 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 client’s 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 in Microbiology or related field with 2+ years of experience in 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

Work Methodology:

Full time, Contract work, Immediate start,