Director of Quality Control

Employer
Aldevron
Location
Fargo, North Dakota
Posted
Feb 20, 2018
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

We are seeking an exceptional leader who thrives in a fast-paced manufacturing environment to oversee all operational aspects of our Quality Control function.  As Director of Quality Control, you have demonstrated leadership ability in large group and team settings.  You have proven problem-solving aptitude and multi-tasking skills.  You have strong collaboration and communication skills, and can interface effectively with all levels of an organization. 

About the Role:

As Director of Quality Control, you will have oversight of all operational aspects of the Quality Control function. This includes project management, method development and validation, raw data/protocol/report review, in-process and product release testing, stability programs, data trending, reference standards, external auditing, deviations, CAPAs, OOSs/OOTs), change control and compliance. You will act as subject matter expert with external clients and regulatory agencies on all QC matters.  You will ensure Quality Control personnel are properly trained and the appropriate resources are provided to successfully fill the job requirements. You will assess talent to assign tasks, functions, and projects to personnel with the appropriate capabilities and experience.

About You:  

  • Previous experience in managing a Quality Control department in biotech/pharmaceutical industry in a cGMP environment is required
  • At least 5 years of industry experience is required
  • Experience developing and qualifying biological methods in one of the following areas: cell-based assays, qPCR assays, HPLC, and microbiological assays   
  • Experience implementing and maintaining departmental metrics 
  • Prior experience working with external testing laboratories, preferred  
  • Experience drafting protocols, data reports and QC/QA compliance documents required 

About the Role:

As Director of Quality Control, you will have oversight of all operational aspects of the Quality Control function. This includes project management, method development and validation, raw data/protocol/report review, in-process and product release testing, stability programs, data trending, reference standards, external auditing, deviations, CAPAs, OOSs/OOTs), change control and compliance. You will act as subject matter expert with external clients and regulatory agencies on all QC matters.  You will ensure Quality Control personnel are properly trained and the appropriate resources are provided to successfully fill the job requirements. You will assess talent to assign tasks, functions, and projects to personnel with the appropriate capabilities and experience.

About You:  

  • Previous experience in managing a Quality Control department in biotech/pharmaceutical industry in a cGMP environment is required
  • At least 5 years of industry experience is required
  • Experience developing and qualifying biological methods in one of the following areas: cell-based assays, qPCR assays, HPLC, and microbiological assays   
  • Experience implementing and maintaining departmental metrics 
  • Prior experience working with external testing laboratories, preferred  
  • Experience drafting protocols, data reports and QC/QA compliance documents required 

Education:

  • BS or MS in, Cell Biology, Molecular Biology, Biochemistry or a related discipline with 5-7 years industry experience

Who Is Aldevron?

Aldevron is a leader in advancing biological science. Our custom development and manufacturing services provide scientists around the world with the essential components to accelerate research and open up their laboratories for groundbreaking science and breakthrough discoveries.

Why Choose Aldevron?

We are in a landmark moment in the history of life science, and Aldevron is at the center of it. With our commitment to quality, we provide career opportunities that allow employees to grow and succeed, while helping make everybody’s lives better.