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Quality Lab Associate III

1 month ago

marion, United States Kelly Science, Engineering, Technology & Telecom Full time

Kelly is hiring a Quality Lab Associate III for one of our clients in Marion, NC


Description:


**Microbial Investigations

  • 1st shift typical hours but will need flexibility to come in on off shifts as part of investigations.
  • 6 positions open
  • 6 month contract (may be extended/converted)
  • Pay: $32-$36/hr


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'll 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 Baxter practices and procedures

• Understands and implements procedures that support implementation of CAPAs

• Presents and defends investigations during regulatory inspections, as required


What you'll 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