Quality Lab Associate III
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Immediate need for a talented Quality Lab Associate III. This is a 06+ Months Contract opportunity with long-term potential and is located in Marion, NC (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job ID:24-47716
Pay Range: $36 - $37/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan.
Key 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 practices and procedures
- Understands and implements procedures that support implementation of CAPAs
- Presents and defends investigations during regulatory inspections, as required.
Key Requirements and Technology Experience:
- Skills-Quality Lab, Root Cause Investigations, Medical/Pharma device.
- Bachelor s 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.
- 1st shift typical hours but will need flexibility to come in on off shifts as part of investigations.
Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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