Microbial Investigation Specialist

2 weeks ago

Marion, United States Intellectt Inc Full time

Title: QLA III – Microbial Investigations

Location: Marion, NC - Onsite


This is where your creativity addresses challenges

The MO (Microbial Out-of-Limits) 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.


What you will be doing

 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 practices and procedures

 Understands and implements procedures that support implementation of CAPAs

 Presents and defends investigations during regulatory inspections, as required


What you will bring

 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

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