Job Description
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:(phone number removed)
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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Job Tags
Permanent employment, Contract work, Local area, Immediate start, Shift work, Day shift,