MQA Specialist I

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

Job summary

Fresenius Kabi USA, LLC is seeking a quality assurance professional responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in response to deviations; ensures SOP and cGMP compliance; maintains the finished product reserve sampling and FDA retention sample storage areas.

On the shop floor, QA drives continuous quality improvement, can stop production for critical deviations, escalates issues with

Qualifications

• Knowledge of SOPs and cGMP compliance.
• Ability to perform investigations and CAPAs.
• Experience with on-the-floor QA oversight.

Responsibilities

• Drive continuous quality improvement with shop-floor presence.
• Authorise stopping production and containment of materials with immediate effect when critical deviations are noted.
• Escalate isolated and systemic issues to site management with proposed CAPAs.
• Oversee shop-floor activities including weighing, bulk solution prep, and in-process controls.
• Support investigations, root-cause analyses, and documentation reviews for GMP compliance.

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.