What are the responsibilities and job description for the Supplier Quality Specialist position at Avecia?
Avecia: Milford, MA, Massachusetts, US
Regular Full Time
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.
