On-Floor Quality Ops Associate — GMP & Compliance

Kedrion Biopharma Inc.; Melville (NY); On-site; USD 55,000 - 82,000; 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 Quality Operations Associate to help ensure quality, compliance, and operational excellence on the production floor. You will work with Manufacturing and Quality teams to monitor activities, review documentation, and identify compliance issues in real time.

This daytime role supports plasma-derived therapeutic production in a highly regulated GMP environment and offers opportunities to develop a quality career in a life sciences setting.

Qualifications

• Experience in pharmaceutical manufacturing or quality operations preferred.
• Knowledge of GMP and GDP regulations in a regulated environment.
• Strong attention to detail and ability to review documentation accurately.
• Effective written and verbal communication skills.

Responsibilities

• Provide on-floor quality support for manufacturing operations and production activities.
• Monitor batch processing activities to ensure compliance with procedures and cGMP.
• Conduct routine inspections of manufacturing areas, equipment, and facilities.
• Review production logbooks and batch records for accuracy and compliance.
• Verify critical process parameters and support in-process quality reviews.
• Identify, document, and communicate quality observations in a timely manner.
• Maintain documentation in accordance with GMP and GDP requirements.
• Assist with SOP revisions and GMP-controlled documents.
• Collaborate with cross-functional teams to support readiness and efficiency.
• Participate in investigations, deviations, and quality system activities.

Skills

Quality Operations

GMP

Documentation review

cGMP

Microsoft Office

Team collaboration

Education

College degree

Job description

Kedrion Biopharma Inc. is seeking a Quality Operations Associate to help ensure quality, compliance, and operational excellence on the production floor. You will work with Manufacturing and Quality teams to monitor activities, review documentation, and identify compliance issues in real time.

This daytime role supports plasma-derived therapeutic production in a highly regulated GMP environment and offers opportunities to develop a quality career in a life sciences setting.