Immediately looking to hire a motivated Senior Quality Specialist who will be responsible for quality tasks and operations. This person will lead change control process, corrective and preventative action (CAPA) systems, as well as schedule, coordinate and conduct audits of suppliers.
location: Dayton, New Jersey
job type: Contract
salary: $65 - 75 per hour
work hours: 9 to 5
- Build a strong working relationship with functions such as purchasing, manufacturing, etc., when dealing with requirements for manufacturing and supply chain integrity.
- Coordinate and perform auditing of suppliers. Including onsite audits of contract manufacturers and other key suppliers.
- Manage supplier qualification process ensuring procedures are executed accordingly and all suppliers are approved prior to purchasing from them. Responsible for approval and disapproval of suppliers.
- Coordination and resolution of supplier quality issues. Includes investigation, resolution, follow-up and corrective actions.
- Experience and/or Education:
- Bachelor's degree required
- 8 years' related experience required:
- Experience in a FDA regulated environment: Pharmaceutical and Medical Devices
- Experience in training, investigations, root cause analysis, Corrective Action Preventive Action (CAPA), auditing (internal and suppliers), leading process improvement, recall, customer complaints, leading regulatory audits, and product quality reviews.
- Experience with monitoring and assurance of sterile manufacturing compliance
- Certifications preferred:
- cGMP or ISO Auditor, Food Safety, HACCP
skills: Quality control, Quality Assurance, GMP (Good Manufacturing Practice), LIMS (Laboratory Information Management System
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.