Supplier Quality Specialist

About this opportunity :

As a Supplier Quality Specialist you will handle the raw material management and supplier qualification program. The role will coordinate key elements of raw material/supplier qualification, QA release, and Quality system metric tracking to ensure all regulatory and customer expectations are fulfilled. 

Key Responsibilities:

•    Own develop and maintain supplier quality management procedures and guidelines.
•    Support supplier audits, assessments and inspections to verify compliance with quality standards and specifications.
•    Deploy quality risk management principles to ensure appropriate risk mitigation and controls exercised.
•    Maintain precise documentation and records related to quality management activities. 
•    Prepare and deliver reports on supplier quality performance to management. 
•    Analyze data to uncover trends and identify areas for enhancement. 
•    Utilize statistical tools to support quality analysis and informed decision-making regarding suppliers.
•    Initiate and facilitate corrective and preventative actions for quality issues or non-conformances.
•    Provide technical guidance and support for laboratory, procurement, engineering and production teams on materials and services selection, evaluation and qualification.
•    Provide and monitor developed Quality KPI’s
•    Establish and implement relative quality assurance protocols and procedures. 
•    Support routine internal audit and supplier audit processes to verify adherence to quality standards. 
•    Maintain a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Required Skills/Abilities:

•    Bachelor of Science degree, with Science and/or Chemistry background. 
•    1-3 years’ experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
•    Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
•    Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
•    Problem-solving skills with the ability to adapt to changing priorities and timelines.
•    Experienced in the use of electronic systems such as SAP, eQMS. 
•    Ability to build positive working partnerships with other department teams.