Quality Lab Associate III (Microbial Investigations) - DivIHN Integration Inc
Marion, NC
About the Job
For further inquiries regarding the following opportunity, please contact one of our Talent Specialists:
Meghna at 224 369 4230
Meghna at 224 369 4230
Meenakshi at 630 847 1776
Hema Malini at 630 847 0275
Infant at 224 507 1261
Exciting Career Opportunity: Quality Lab Associate III (Microbial Investigations)!
Are you looking to gain hands-on experience with a global leader in medical technology? Join DivIHN Integration in partnering with a top-tier client in Marion, NC, and be part of a team that's making a difference in healthcare!
Position Highlights
Role: Quality Lab Associate III (Microbial Investigations)
Location: Marion, NC
Duration: 6 months
Eligibility: OPT/CPT-EAD candidates are encouraged to apply!
Why This Opportunity?
Our client is a trusted name in healthcare, specializing in Renal Care, Hospital Care, Surgical Care, Nutritional Care, and Respiratory Care. As a Quality Lab Associate or Lab Technician, you'll contribute to the production of life-changing medical products used in healthcare settings worldwide!
Hiring Process
- Single Video Interview with a DivIHN Account Manager
- Decision Made on Resume Quality: The hiring manager will assess resumes from all suppliers to make final decisions.
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 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.
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.
Your Team at Client
- Within Quality, every role makes a difference.
- Products that client makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen 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 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 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, 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
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.
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.
About us:
DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West 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.
Source : DivIHN Integration Inc
