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Quality Assurance Specialist II in Fargo, North Dakota For Sale

Type: Misc, For Sale - Private.

Basic Function:
The Quality Assurance Specialist II is responsible for supporting the quality system processes including Internal Audits, CAPAs, Document Control and Supplier Quality.
Essential Functions and Skills:
Responsible for maintaining quality assurance standards, processes and controls. Develops and implements methods for inspection, testing, sampling, and training.
Support quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products.
Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual.
Expected to be familiar with all of Aldevron's products and services and all associated systems with a good understanding of molecular biology, microbiology, biochemistry and cell biology.
Identifies compliance risks at Aldevron through auditing process.
Support of the CAPA system.
Support of Aldevron's internal audit program.
Support of the qualification and monitoring of Aldevron's suppliers/vendors.
Support of maintaining the Document Control process by ensuring all quality records within the Document Control system are maintained effectively.
Support Quality Assurance involvement in and review of change management and change control requests
Support GMP Manufacturing activities.
Support of Aldevron's validation process by generating protocols, testing plans and final reports, as assigned, to meet internal SOPs and regulatory requirements.
Provide support during external inspections performed of Aldevron by regulatory agencies /clients and leading corrective actions resulting from inspection findings.
Knowledge/Education Requirements:
Bachelor's degree in science or related field
At least 3 years of Quality Assurance or Regulatory Compliance experience in GxP environment
Aldevron is a custom manufacturing organization that provides plasmid, protein and antibody development and production services. Headquartered in Fargo, ND with locations in Madison, WI and Freiburg, Germany we constantly look to innovate and advance life science through collaborative partnerships. Aldevron works with leaders in pharmaceutical, biotech and research institutions around the world to accelerate the development of drug, treatment and preventions for numerous diseases and genetic disorders. Our reputation for innovative solutions for our clients has allowed us to expand our organization and offerings in all service platforms. We are working in a landmark moment in the history of life science.
https://www.applicantpro.com/j/xxxx20

State: North Dakota  City: Fargo  Category: Misc
Misc in North Dakota for sale

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