Shop Floor QA Specialist I — Quality & Compliance

Fresenius Kabi USA; Wilson (NC); On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA is seeking a QA professional to oversee quality in production, assist with process improvements, and ensure adherence to SOPs and cGMPs. The role supports production, labs, and related departments, maintaining sample storage and final product reserves as required by FDA retention practices.

Key duties include stopping production for critical deviations, leading investigations and CAPAs, and serving as the on-floor QA contact to document issues and ensure QA compliance.

Responsibilities

• Drive a culture of continuous quality improvement by on the shop-floor presence
• Act with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered to
• Authorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are noted
• Escalate Isolated and Systemic issue to site management, including proposed CAPAs
• QA key contact to shop floor employees and on the floor QA contact to elevate issues and provide real-time documentation requirements/trouble shooting analysis
• Participate in 5S activities
• Support investigations & root-cause analyses (incidents & investigations)
• Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance
• Support quality and compliance and continuous Improvement projects
• Special oversight activities (media fills, repackaging, reworking, validation/investigation study activities)

Job description

Fresenius Kabi USA is seeking a QA professional to oversee quality in production, assist with process improvements, and ensure adherence to SOPs and cGMPs. The role supports production, labs, and related departments, maintaining sample storage and final product reserves as required by FDA retention practices.

Key duties include stopping production for critical deviations, leading investigations and CAPAs, and serving as the on-floor QA contact to document issues and ensure QA compliance.