MQA Specialist I

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

Benefits offered by this job

Medical, dental, and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in Wilson, NC seeks a Quality Assurance professional responsible for quality oversight of production processes, supporting departments and labs, ensuring adherence to SOPs and cGMPs.

The role includes real-time on-floor QA, stop-work authority for critical deviations, escalation to management, CAPA investigations, 5S participation, and thorough documentation of MBRs and logbooks.

Salary range and benefits reflect a competitive package; at-will employment.

Qualifications

• Quality oversight on shop-floor and adherence to SOPs and cGMP requirements.
• Ability to authorize stop-work actions for critical deviations.
• Escalation to site management with proposed CAPAs.
• Participation in 5S and continuous improvement activities.
• Review of MBRs and GMP/logbook documentation for compliance.

Responsibilities

• Drive continuous quality improvement on the shop floor.
• Stop production activities and contain materials with immediate effect for critical deviations.
• Escalate isolated and systemic issues to site management with proposed CAPAs.
• Perform shop-floor QA documentation and 5S activities.
• Support investigations and root-cause analyses; review logs and MBRs.

Skills

Quality Assurance

cGMP compliance

Shop-floor QA

CAPA investigations

5S

Documentation

In-Process Controls

Visual Inspection

Job description

Job SummaryPosition 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.ResponsibilitiesDrive a culture of continuous quality improvement by on the shop-floor presenceAct with competency, integrity and appropriately as Quality Assurance personnel and assure that the processes required are adhered toAuthorized to stop production activities and contain materials and/or products with immediate effect where Critical Deviations are notedEscalate Isolated and Systemic issue to site management, including proposed CAPAsMQA 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 verificationBulk Solution PreparationComponent Preparation identification and verificationMonitoring of In-Process ControlsOversight 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 planPerformance of Visual Inspection (AQL)Packaging oversightWarehousing/Storage requirement adherenceMonitoring of Facilities and Utilities per required parametersQA key contact to shop floor employeesOn the floor QA contact to escalate issues and provide real-time documentation requirements/trouble shooting analysisParticipate in 5S activitiesSupport in investigations & root-cause analyses (incidents & investigations)Shop-floor documentation review of MBRs and logbooks for GMP and procedural complianceSupport quality and compliance and continuous Improvement projectsSpecial oversight activities based on case by case demand to include but not limited to:media fillsrepackagingreworkingvalidation/investigation study activitiesother duties as assignedSalary Range: $60,966-$85,694Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision 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 permanent employment arrangement. All employment is at‑will, 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.