GMP Manufacturing Quality Associate (Temp) - Onsite

Kedrion Biopharma GmbH; Melville (NY); On-site; USD 32,000 - 34,000; Full time

Benefits offered by this job

Medical, vision and dental insurance

Life and AD&D insurance

Paid holidays

PTO accrual

and much more!

Job summary

Kedrion Biopharma Inc. is seeking a Manufacturing Quality Associate for a day shift on a temporary basis in Melville, NY.

The role sits on the production floor in a GMP-regulated environment, supporting quality oversight, batch review, and documentation to ensure compliance with procedures and regulatory standards. You will collaborate with Quality, Operations, and Engineering to monitor activities, perform inspections, and initiate non-conformance reports while contributing to continuous

Qualifications

• College degree preferred or equivalent combination of education and relevant experience required.
• Experience in a pharmaceutical manufacturing, Quality, or Operations environment preferred.
• Experience supporting biologics manufacturing, Quality Assurance, or production operations is a plus.
• Knowledge of GMP and GDP regulations and working in a regulated pharmaceutical environment.

Responsibilities

• Provide on-floor quality support for manufacturing operations within a GMP-regulated environment.
• Monitor batch processing activities to ensure compliance with procedures, batch records, and cGMP requirements.
• Conduct routine inspections of production areas, equipment, systems, utilities, and facilities using checklists.
• Review production logbooks and batch records, including verification of critical process parameters.
• Support plasma and component inspection activities as required.
• Identify, document, and communicate quality observations in real time to support compliance.
• Track and trend documentation observations to support quality metrics and improvement initiatives.
• Initiate and document minor non-conformance reports.
• Review critical system and utility alarms to assess compliance and impact.
• Maintain accurate, complete, and timely documentation per GMP and GDP.

Skills

GMP compliance

Documentation review

On-floor quality support

Communication skills

Team collaboration

Education

College degree or equivalent

Tools

Microsoft Office

Email systems

Job description

Kedrion Biopharma Inc. is seeking a Manufacturing Quality Associate for a day shift on a temporary basis in Melville, NY.

The role sits on the production floor in a GMP-regulated environment, supporting quality oversight, batch review, and documentation to ensure compliance with procedures and regulatory standards. You will collaborate with Quality, Operations, and Engineering to monitor activities, perform inspections, and initiate non-conformance reports while contributing to continuous