Über die Tätigkeit

The Supply Chain Quality Specialist is responsible for providing Quality oversight to all suppliers and vendors to ensure that all incoming materials meet specifications. 

 

Responsibilities include, but are not limited to:

 

•      Inspect and qualify suppliers 

• Set processes in place for sampling plans related to raw materials and components

• Develop Standard Operating Procedures as needed related to Incoming Materials 

• Periodically review records to verify quality standards for drug product per FDA guidance 

• Maintain compliance with FDA 503B and cGMP guidelines / state and federal laws for suppliers

• Prepares weekly/monthly reports pertaining to  metrics and trends related to suppliers

• Work in collaboration with Supply Chain and Quality Director on unexpected events for prompt                             resolution

• Assists in maintaining compliant controlled substance documentation specifically associated with

      sample handling and reconciliation

• Evaluate like for like components from different suppliers

• Conduct periodic internal reviews or audits to ensure that compliance procedures are followed

• Conduct and report the findings of internal and external investigations of compliance issues

 

Ihr Profil

• BS/BA degree with 5 years of manufacturing industry experience in supply chain or a combination of                   education and related experience

• Minimum 2 years directly related experience supporting supply chain

• Experience qualifying suppliers or vendors

• Ability to manage multiple vendors, suppliers, and distributors 

• Experience overseeing receiving of materials is preferred 

• Experience with FDA inspections is preferred 

• Experience managing sampling of raw materials

• Experience reading and writing technical work instructions 

 

 

Unser Angebot

Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.

 


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