Quality Assurance Specialist at The Fountain Group

Pay: $37
Duration: 8 months with the possibility of extension
Location: Onsite

Brief Job Description:
The QA Specialist role is responsible for maintaining the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. Provides support and guidance to other functional teams in Operations, QC, and Quality primarily through Quality Documentation activities.

Job Responsibilities:

• Support Quality, Compliance, and Operational risks via ownership and continuous improvement of the following business processes:
  • GxP Documentation Management
  • Quality Management Review
  • Annual Product Quality Review
  • Internal Quality Standard Assessments
  • Other Compliance Processes As Applicable
• Utilizes Lean principles, mindset, and ways of working such as problem-solving, 5S, and visual management.
• Provides guidance to the cross-functional working team(s) to ensure compliant and timely execution Quality Documentation tasks such as archiving, logbook preparation, etc.
• Becomes actively involved in daily operations when required to meet schedules or to resolve problems.

Skills and Experience
Essential:

• Intermediate proficiency in Microsoft Office Suite (Primarily Teams, Word, Excel, and PowerPoint)
• Highly organized
• Strong detail orientation
• Strong critical thinking

Desirable:

• Experience supporting the Quality Assurance teams in a manufacturing or pharmaceutical organization
• Experience working in Document Management System (Veeva preferred)
• Experience with data processing
• Education:
• High School or equavilient
• Some college preferred