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location: Marion, North Carolina
job type: Contract
salary: $25.56 - 30.07 per hour
work hours: 9 to 5
The role of Quality Laboratory Associate II (QLAII) - Microbiology Investigator is primarily responsible for conducting investigation of microbial out of limits (MO) that occur in cleanroom locations including environmental and product solution excursions.
- Conducting the investigation of these occurrences using root cause analysis tools to determine potential root cause and contributing factors and defining effective corrective and/or preventive actions (CAPA) to prevent recurrence
- Partnering with other departments throughout the facility including Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure appropriate and timely determination of scope, product impact, root cause, and CAPAs.
- Participation with colleagues to perform investigation activities as needed to support non-conformance investigations
- Assembling cross-functional teams, conducts interviews, observes operations to complete investigations and lead process improvement CAPA projects to timely and effective closure
- Fostering collaborative relationships focused on high-quality and timely investigations, effective corrective actions and the reduction of out-of-limit generation rate
- Closing investigations in a timely manner to meet business and compliance needs
- Working with minimal supervision to drive investigations to closure
- Working with Subject Matter Experts and Quality Approvers to determine scope, identify root cause(s), and implement corrective/preventive actions
- Managing CAPA documentation in TrackWise in compliance with Baxter practices and procedures
- Presenting investigations during regulatory inspections
- Bachelor or Masters degree in science, preferably in Biology or Microbiology
- Minimum of two (2) years experience in a role related to microbiology
- 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, Fishbone Diagram)
- 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
skills: Project Management, Quality control, FDA, CAPA, Microbiology, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.