MQA Specialist I

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

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company match

Wellness program

Job summary

Fresenius Kabi in the United States is seeking a Quality Assurance professional to oversee production quality, support departments and laboratories, and ensure adherence to SOPs and cGMPs. This role includes real-time issue documentation, packaging oversight, and CAPA coordination on the shop floor.

Responsibilities include stopping production for critical deviations, leading investigations, and ensuring compliant finished product sampling and storage in line with regulatory requirements.

Qualifications

• QA on the shop floor to ensure GMP/compliance.
• Ability to stop production for critical deviations.
• Support investigations and root-cause analyses with real-time documentation.

Responsibilities

• Drive continuous quality improvement on the shop floor.
• Ensure processes comply with SOPs and cGMPs.
• Contain materials/products and notify management of deviations.
• Coordinate CAPAs and monitoring of in-process controls.
• Oversee packaging, warehousing, and final product checks.

Skills

Quality Assurance

cGMP

CAPA

5S

Root Cause Analysis

Documentation

Shop-floor presence

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 andvision coverage, as well as life insurance, disability, 401K with company contribution,and wellness program.

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.