Manufacturing QA Specialist

Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.

Manufacturing Quality Assurance Specialist (MQA) on the Operations floor performs routine inspections of production activities, systems, utilities, and facilities for their compliance with the established procedures, batch records and cGMP requirements. The specialist is available on the Operations floor working together with Operations departments to assure all standard procedures, regulations and guidelines are followed in the manufacturing, filling, inspection and packaging of company products and to ensure compliance issues are detected and solved in real time. The Manufacturing Quality Specialist performs routine reviews and compliance evaluations of production batch records and logbooks, calibration and maintenance records, environmental and other critical systems monitoring results and conducts investigations as necessary. The Manufacturing Quality Specialist supports plasma, syringe and other inspections.

Main Responsibilities

The MQA Specialist monitors batch processing activities including also systems, utilities, and facilities 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 in-process and post-production reviews of batch records and production logbooks.
• Line clearances as per Operations schedule.
• Filling, post filling, AQL and finished labeling inspections of aseptic drug products.
• Assistance with media fill study.
• Assistance with plasma, intermediates, labeling and packaging component inspections.
• Assistance with pooling activities.
• The MQA Specialist is available on the Operations floor supporting Operations departments to ensure deviations and compliance issues are detected, reported and solved in real time.
• The MQA helps with interventions, return to service actions and investigations of environmental and other critical systems/utilities.
• The MQA conducts manufacturing investigations as needed, collects data, prepares trending reports, develops and/or revises standard operating procedures.
• If assigned, the MQA Specialist performs routine reviews and approves standard reports for Building Automation/Building Management, Calibration, Work Orders and Preventive Maintenance systems.
• If assigned, the MQA maintains receiving, inspection and release of labeling and packaging components:
• Change control and revision of packaging /labeling component specifications
• Receiving, sampling, proofreading and releasing incoming shipments
• Management of labeling/packaging component Master print files
• Line clearance label verification and packaging authorization.
• If assigned, the MQA Specialist participates in departmental and interdepartmental teamwork to support site and organizational goals and objectives. He/she performs other tasks, projects or assignments as directed by the QA Supervisor/Manager.
• The MQA Specialist 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/experience
• 5 years of pharmaceutical experience in Quality or Operations department.
• Experience with biologics Quality Assurance or Operations plus.
• Plasma fractionation, aseptic filling and labeling experience plus.
  
  

Other Requirements

Travel may be required, less than 10%

Kedrion Biopharma offers a number of benefits to qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!
  
  

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.