Manufacturing QA Specialist

Kedrion Biopharma • Melville, NY

409d

About The Position

The Manufacturing Quality Assurance Specialist (MQA) at Kedrion Biopharma plays a crucial role in ensuring compliance with established procedures, batch records, and cGMP requirements on the Operations floor. This position involves routine inspections, documentation, and collaboration with Operations departments to address compliance issues in real time, thereby supporting the production of high-quality plasma-derived products.

Requirements

• College degree or equivalent education/experience
• 5 years of pharmaceutical experience in Quality or Operations department
• Experience with biologics Quality Assurance or Operations is a plus
• Knowledge of plasma fractionation, aseptic filling, and labeling is a plus
• Strong communication skills, both verbal and written
• Problem-solving skills and results-oriented approach
• Proficiency in Microsoft Office and email

Nice To Haves

• Experience with pharmaceutical investigation
• Strong quality culture orientation
• Focus on delivering excellent customer service

Responsibilities

• Monitor batch processing activities for compliance with established procedures and cGMP requirements.
• Conduct routine inspections and documentation of Operations floor activities, systems, utilities, and facilities.
• Perform in-process and post-production reviews of batch records and production logbooks.
• Execute line clearances as per Operations schedule.
• Conduct filling, post-filling, AQL, and finished labeling inspections of aseptic drug products.
• Assist with media fill studies and plasma, intermediates, labeling, and packaging component inspections.
• Support pooling activities and interventions for compliance issues.
• Conduct manufacturing investigations, collect data, and prepare trending reports.
• Review and approve standard reports for Building Automation/Management, Calibration, Work Orders, and Preventive Maintenance systems as assigned.
• Maintain receiving, inspection, and release of labeling and packaging components as assigned.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree