Quality Lab Associate III Microbial Investigations
Quality Lab Associate III Microbial Investigations
Posted on :
03-11-2024
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Job Description
For further inquiries regarding the following opportunity please contact one of our Talent Specialists:
Meghna at
Meghna at
Meenakshi at
Hema Malini at
Title: Quality Lab Associate III (Microbial Investigations)
Location: Marion NC
Duration: 6 Months
1st shift typical hours but will need flexibility to come in on off shifts as part of investigations.
Description:
This is where your creativity addresses challenges
The MO (Microbial OutofLimits) 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.
This is where your creativity addresses challenges
The MO (Microbial OutofLimits) 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.
Your Team at Client
Within Quality every role makes a difference. Products that client makes are shipped worldwide for patients in need. Whether its building a new process from scratch or facing a neverbeforeseen production hurdle individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product it is sure to touch a portion of our global operation.
The mission of client is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds we will always choose quality. Our patients come first always.
Within Quality every role makes a difference. Products that client makes are shipped worldwide for patients in need. Whether its building a new process from scratch or facing a neverbeforeseen production hurdle individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product it is sure to touch a portion of our global operation.
The mission of client is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds we will always choose quality. Our patients come first always.
What youll be doing
Determines scope product impact root cause corrective and/or preventive actions of microbial excursions including surfaces viable air nonviable air water bioburden and endotoxin testing results
Expeditiously identifies potential root causes for excursions and immediate mitigation actions
Assembles crossfunctional teams conducts interviews observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
Fosters collaborative relationships focused on highquality and timely investigations effective corrective actions and the reduction of outoflimit 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
Determines scope product impact root cause corrective and/or preventive actions of microbial excursions including surfaces viable air nonviable air water bioburden and endotoxin testing results
Expeditiously identifies potential root causes for excursions and immediate mitigation actions
Assembles crossfunctional teams conducts interviews observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
Fosters collaborative relationships focused on highquality and timely investigations effective corrective actions and the reduction of outoflimit 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
What youll bring
Bachelor or Masters 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 problemsolving 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
Bachelor or Masters 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 problemsolving 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
About us: DivIHN the IT Asset Performance Services organization provides Professional Consulting Custom Projects and Professional Resource Augmentation services to clients in the MidWest and beyond. The strategic characteristics of the organization are Standardization Specialization and Collaboration. DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race color religion (creed) gender gender expression age national origin (ancestry) disability marital status sexual orientation or military status.
Employment Type
Full Time
Key Skills
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