Quality Lab Associate II- Kronos

  • location: Marion, NC
  • type: Contract
  • salary: $25.56 - $30.07 per hour
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job description

Quality Lab Associate II- Kronos

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!

 
location: Marion, North Carolina
job type: Contract
salary: $25.56 - 30.07 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
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
 
qualifications:
  • 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.

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