MQA Specialist

Fresenius Kabi USA, LLC; Wilson (NC); 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 is seeking a Quality Assurance professional to oversee manufacturing quality, advise production, and ensure cGMP compliance across departments and laboratories. The role involves real‑time issue containment, deviation investigations, and documentation review to maintain product integrity and regulatory readiness.

The position emphasizes 5S, continuous improvement, and collaboration with QA and production teams to support quality and compliance initiatives in a fast-paced

Qualifications

• Responsible for quality oversight and ensuring compliance with SOPs and cGMPs.
• Participates in investigations and CAPA activities to resolve deviations.

Responsibilities

• Drive a culture of continuous quality improvement on the shop floor.
• Assert authority to stop production when Critical Deviations are observed.
• Escalate issues to site management with proposed corrective actions.
• Support QA on filling, packaging, and warehouse processes to ensure GMP adherence.
• Review MBRs and logbooks for compliance and documentation accuracy.

Skills

Quality Assurance

GMP Compliance

Root Cause Analysis

Documentation

Investigations

5S

Job description

Job Summary

Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and cGMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.

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
• MQA shop-floor activities must cover the entire production and support processes which, depending upon the plant's business operations will include but not limited to:
• Weighing and Dispensing verification
• Bulk Solution Preparation
• Component Preparation identification and verification
• Monitoring of In-Process Controls
• Oversight of Filling/Lyophilization activities (including completion of Aseptic Gowning Qualification)
• Finishing Activities, including Integrity Testing Verification, adherence of general inspection requirements/timelines, execution of sampling plan
• Performance of Visual Inspection (AQL)
• Packaging oversight
• Warehousing/Storage requirement adherence
• Monitoring of Facilities and Utilities per required parameters
• QA key contact to shop floor employees
• On the floor QA contact to elevate issues and provide real-time documentation requirements/trouble shooting analysis
• Participate in 5S activities
• Support in 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 based on case by case demand to include but not limited to:
• media fills
• repackaging
• reworking
• validation/investigation study activities
• other duties as assigned

Salary Range: $60,966-$85,694

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.