MQA SPECIALIST II

Company: Fresenius Kabi AG
Location: Wilson
Posted on: September 18, 2022

Job Description:

Job Summary

Performs routine audits and inspections of manufacturing areas to ensure product quality, SOP and GMP compliance. Provides plant support for collection of data where needed, while assembling required metrics for review by facility management. Updates controlled documents, including SOPs, policies and batch records to maintain a state of Quality Control in the production areas.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

• Performs audits of all operating areas and participates in scheduling of the internal audit program. Issues results to area supervision. Ensures issues are reviewed and corrective action implemented.
• Performs AQL checks on product when necessary and maintains Inspector and AQL qualification status.
• Addresses daily quality concerns and questions related to operations and environmental concerns. Implements and follows up on corrective actions.
• Provides additional support for batch record review and critical processing steps in order to meet production and release scheduling.
• Becomes gown qualified and maintains status for entry into Aseptic processing area in order to investigate potential deviations and compliance risks.
• Assures standard operating procedures (SOPs) and batch records define the steps necessary to complete tasks. Writes, reviews, and updates documents as needed.
• Identifies and initiates deviations in the production areas, assures products are placed on SAP hold as required and initiates and executes Action Plan requirements as needed to address investigation or compliance related activities.
• Collects inspection, particulate matter, AQL and re-inspection reject data when needed and analyzes trend data.
• Assists in analysis of inspection rejects; assists in investigation of causes and implementation of corrective action using TrackWise or other approved investigational tools.
• Provides plant support where necessary for troubleshooting of manufacturing problems or special projects as needed.
• Attends plant meetings, communicates quality notes and provides necessary support with ECRs, EODs, etc.
• Calculates, revises or reviews SPC limits for filling operations. Performs analysis for fill operations utilizing Statistical Process Control.
• Supports validation projects with required data collection. May function as a Study Director for qualifications and/or investigative studies.
• Issues/aprovs ECR using Trackwise.
• Performs Mean Kinetic Temperature (MKT) calculations.
• Performs additional duties and responsibilities as assigned.
• May become a qualified trainer.
  
  REQUIREMENTS
  
  • Bachelor of Science degree or three (3) to five (5) years equivalent education/professional experience required.
  • Pharmaceutical industry experience desirable.
  • Knowledge of a production facility and/or inspection processes are a must.
  • Oral and written communication skills required between department, as well as levels of management.
  • Computer experience required. Must be proficient in Microsoft Word and Excel functions
    
    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 match, and wellness program.
    
    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.

Keywords: Fresenius Kabi AG, Wilson , MQA SPECIALIST II, Other , Wilson, North Carolina