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Manufacturing Quality Associate

3 months ago

Melville, United States Kedrion Biopharma Full time

Scope: Manufacturing Quality Assurance (MQA) Associate performs routine inspections of production activities. The Associate is available on the Operations floor working together with other MQAs and Operations departments to ensure compliance issues are detected and solved in real time. The Associate performs in-process reviews of production batch record and logbooks.


This is a night shift position and pays a 10% shift differential. The hours are 6:00pm - 6:00am Week 1: Mon, Tues, Fri, Sat (off Wed/Thurs) Week 2: Sun, Wed, Thurs (off Mon, Tues, Fri & Sat) alternating

Main Responsibilities:

  • The MQA Associate monitors batch processing activities for their compliance with the established procedures, batch records and cGMP requirements:
  • Routine inspections and documentation of Operations floor activities, systems, utilities, and facilities as per the checklists.
  • Routine review of logbooks and Batch records including the confirmation of Critical Parameters.
  • Line clearances as per Operations schedule.
  • The MQA Associate helps with:
  • Return to Service Actions
  • Review of critical systems/utilities Alarms
  • Work Order /Preventative Maintenance Review
  • Calibration Record Review
  • If assigned, the MQA Associate participates in departmental and interdepartmental teamwork and performs other tasks or assignments as directed by the QA Supervisor/Manager. This may include writing deviations, performing investigations, writing change controls, and executing action items, revising SOPs and other GMP documents.
  • The MQA Associate follows and promotes organizational safety policy.


Knowledge, Skills, and Abilities:


  • Focus on delivering excellent customer service.
  • GMP and strong quality culture oriented individual.
  • Able to communicate both verbal and written.
  • Problem solving skills, results oriented.
  • Experience with pharmaceutical investigation plus.
  • Knowledge of Microsoft Office and e-mail required.


Requirements:

  • College degree or equivalent education preferred /Equivalent experience required.
  • Pharmaceutical experience in Quality or Operations department preferred.
  • Experience with biologics Quality Assurance or Operations plus.
  • Plasma fractionation, aseptic filling, and labeling experience plus.