Onsite Day Shift: Quality Operations Specialist

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

Benefits offered by this job

Medical, vision & dental

Life and AD&D insurance

Paid holidays

PTO accrual

Benefits

Job summary

Kedrion Biopharma Inc. seeks a Quality Operations Associate for a daytime shift, onsite in Melville, NY. The role focuses on quality support in a GMP environment, with close collaboration to manufacturing and QA teams to monitor production activities and maintain compliant documentation.

The position emphasizes investigating deviations, maintaining SOPs, and contributing to continuous improvement while ensuring product quality and regulatory adherence.

Qualifications

• College degree preferred or equivalent combination of education and experience.
• Experience in pharmaceutical manufacturing, QA, or quality operations is preferred.
• Knowledge of GMP and GDP regulations in a regulated environment.
• Experience with biologics manufacturing, plasma fractionation, aseptic filling, or labeling is a plus.
• Strong documentation and communication skills, attention to detail.

Responsibilities

• Provide on-floor quality support for manufacturing operations and production activities.
• Monitor batch processing to ensure compliance with procedures and cgMP requirements.
• Conduct routine inspections of manufacturing areas, equipment, and utilities.
• Review production logs and batch records for accuracy and compliance.
• Verify process parameters and support in-process quality reviews.
• Assist with quality investigations, deviations, and CAPA activities.
• Maintain GMP and GDP documentation and SOPs; support quality system tasks.
• Collaborate with cross-functional teams to ensure readiness and compliance.

Skills

Pharma manufacturing

GMP/GDP knowledge

Quality Assurance

Documentation review

Cross-functional collaboration

Attention to detail

Microsoft Office

Education

College degree preferred

Job description

Kedrion Biopharma Inc. seeks a Quality Operations Associate for a daytime shift, onsite in Melville, NY. The role focuses on quality support in a GMP environment, with close collaboration to manufacturing and QA teams to monitor production activities and maintain compliant documentation.

The position emphasizes investigating deviations, maintaining SOPs, and contributing to continuous improvement while ensuring product quality and regulatory adherence.