QA Specialist - Shop Floor Quality & Compliance

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

Job summary

Fresenius Kabi USA, LLC is seeking a quality assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in response to deviations; ensures SOP and cGMP compliance; maintains the finished product reserve sampling and FDA retention sample storage areas.

On the shop floor, QA drives continuous quality improvement, can stop production for critical deviations, escalates issues with

Qualifications

• Knowledge of SOPs and cGMP compliance.
• Ability to perform investigations and CAPAs.
• Experience with on-the-floor QA oversight.

Responsibilities

• Drive continuous quality improvement with shop-floor presence.
• Authorise stopping production and containment of materials with immediate effect when critical deviations are noted.
• Escalate isolated and systemic issues to site management with proposed CAPAs.
• Oversee shop-floor activities including weighing, bulk solution prep, and in-process controls.
• Support investigations, root-cause analyses, and documentation reviews for GMP compliance.

Job description

Fresenius Kabi USA, LLC is seeking a quality assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in response to deviations; ensures SOP and cGMP compliance; maintains the finished product reserve sampling and FDA retention sample storage areas.

On the shop floor, QA drives continuous quality improvement, can stop production for critical deviations, escalates issues with