Manufacturing QA Specialist – On‑Floor Quality & Compliance

Fresenius SE & Co. KGaA; Wilson (NC); Hybrid; USD 61,000 - 86,000; Full time

Benefits offered by this job

Medical, Dental, Vision coverage

Life Insurance

Disability Insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Wilson, NC seeks a Quality Assurance professional to oversee quality oversight and support to production, departments and labs. The role recommends corrective actions for deviations, ensures SOP and cGMP compliance, and maintains sampling and retention areas for FDA integrity.

Responsibilities include driving continuous quality improvement on the shop floor, stopping production when critical deviations occur, escalating issues with CAPA proposals, and reviewing documentation

Qualifications

• Experience with cGMPs and SOP adherence.
• Ability to stop production and contain materials when critical deviations are noted.
• Strong collaboration with shop floor, QA and production teams.

Responsibilities

• Drive continuous quality improvement with on-floor presence.
• Ensure processes comply with SOPs, cGMPs and QA standards.
• Escalate issues to site management and propose CAPAs.
• Oversee weighing, dispensing, solution preparation and component verification.
• Monitor in-process controls and oversee filling/lyophilization activities.
• Review MBRs and logbooks for GMP compliance; support investigations and root-cause analyses.
• Participate in 5S and other continuous improvement activities.

Skills

Quality Assurance

GMP Compliance

Job description

Fresenius Kabi in Wilson, NC seeks a Quality Assurance professional to oversee quality oversight and support to production, departments and labs. The role recommends corrective actions for deviations, ensures SOP and cGMP compliance, and maintains sampling and retention areas for FDA integrity.

Responsibilities include driving continuous quality improvement on the shop floor, stopping production when critical deviations occur, escalating issues with CAPA proposals, and reviewing documentation