JOB CODE 1920
DURHAM, NC, USA

 

Metabolon, headquartered in Research Triangle Park, NC, is a services company offering metabolomics testing using the industry’s leading Precision Metabolomics™ Opens a New Window. platform. Metabolon’s technology and expertise is used to accelerate research Opens a New Window. and product development across the pharmaceutical,
biotechnology, consumer products, agriculture and nutrition industries, as well as academic and government organizations. Metabolon offers scalable, customizable metabolomics solutions across the research continuum from discovery to clinical trials. Due to our rapidly growing business, Metabolon is seeking an energetic and talented individual for the role of Quality Assurance Specialist. The team member in this position will be an integral member of our Medical Affairs team and will report to the Manager of Quality Assurance. The individual in this role will interact in a collaborative manner with all laboratory personnel and other departments at Metabolon and will be
responsible for managing various activities in support of the company’s Quality Management System (QMS). This individual will have experience in Quality Assurance within a GCP or CLIA-regulated environment. This successful candidate will be an individual who is interested in growing his/her career in Quality Assurance and is enthusiastic about being part of a team that is continually improving the quality across the entire business. 

Responsibilities 

The
individual is responsible for the following:  

  • Manage documents within the electronic Document Management System 
  • Manage the document archival process 
  • Manage the implementation and ongoing maintenance of an electronic Quality
    Management application 
  • Document review and formatting (e.g., Microsoft word, excel, Adobe pdf conversion) 
  • Activities to support ISO 9001 implementation  
  • Assist with internal audits and follow up on corrective actions from audit findings      
  • Assist with documentation for CAPA investigations and Change Control management 
  • Assist with external audits 
  • Assist with supplier audit program  
  • Assist laboratory personnel with equipment qualification documentation 
  • Other activities necessary
    to ensure Quality System is in compliance with CAP, GCP, and ISO 9001 Standards 

 Required Experience & Qualifications 

· BS degree is required 

· 3-5 years of experience in a Quality Assurance
role, preferably for a bioanalytical laboratory  

· Organized and has a strong attention to detail 

· Excellent writing skills 

· Strong interpersonal skills, with a
demonstrated ability to interact effectively with multi-functional teams 

· Working knowledge of CLIA, GCP, and/or ISO 9001
Standards  

· Ability to handle multiple priorities
simultaneously 

Principals only, no agencies.  We are not able to sponsor H1B candidates

Metabolon offers a comprehensive benefits program including health, dental, disability and life insurance coverage, a 401(k) with matching savings plan, and paid time off.  To apply for this position, please click on the link below or send cover letter and resume via mail to Metabolon, Inc., Attention: Talent Acquisition, P.O. Box 110407, Research Triangle Park, NC  27709.  Cover letters should reference the job title above. No phone calls please.

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