QA Shop-Floor Specialist I – Quality & Compliance

301044 Fresenius Kabi USA, LLC; Kansas; On-site; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC in Kansas is seeking a Quality Assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. The role recommends corrective action in response to deviations and ensures compliance with SOPs and cGMPs.

Maintains proper sampling and FDA retention sample storage areas. You will drive a culture of continuous improvement on the shop floor, have authority to stop production when critical deviations

Qualifications

• Quality assurance background required.
• Knowledge of cGMPs and SOPs.
• Ability to document and escalate issues clearly.

Responsibilities

• Drive a culture of continuous quality improvement by on the shop-floor presence.
• Act with competency and integrity as Quality Assurance personnel and ensure adherence to required processes.
• Authorized to stop production activities and contain materials and/or products with immediate effect when Critical Deviations are noted.
• Escalate isolated and systemic issues to site management, including proposed CAPAs.
• QA shop-floor activities cover weighing/dispensing verification, bulk/component prep, in-process controls, and visual inspections.

Job description

Fresenius Kabi USA, LLC in Kansas is seeking a Quality Assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. The role recommends corrective action in response to deviations and ensures compliance with SOPs and cGMPs.

Maintains proper sampling and FDA retention sample storage areas. You will drive a culture of continuous improvement on the shop floor, have authority to stop production when critical deviations