Night-Shift GMP Quality Associate (Pharma)

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. in Melville, NY is seeking a GMP Quality Associate for an overnight 06:00 pm – 06:00 am shift on site.

You will work on the production floor with Manufacturing and Quality teams to oversee daily operations, review documentation, and help resolve quality issues in real time. This role emphasizes compliance with GMP and GDP, attention to detail, and continuous improvement in a highly regulated environment.

Qualifications

• College degree preferred or equivalent combination of education and experience.
• Experience in pharmaceutical manufacturing, QA, or production environments preferred.
• Knowledge of GMP and GDP regulations in a regulated environment.
• Experience with biologics manufacturing, plasma fractionation, aseptic filling or labeling is a plus.
• Experience supporting investigations, deviations, or quality systems preferred.
• Strong attention to detail and ability to review technical documentation accurately.
• Effective verbal and written communication skills and teamwork.
• Proficiency with Microsoft Office applications and email systems.
• Commitment to safety, quality, regulatory compliance, and continuous improvement.

Responsibilities

• Provide GMP quality oversight for daily manufacturing operations.
• Monitor batch processing activities for compliance with procedures and cGMP.
• Conduct routine inspections of production areas, utilities, and facilities.
• Review production logbooks, batch records, and supporting documentation.
• Verify critical manufacturing parameters and support in-process quality reviews.
• Support plasma and component inspection activities.
• Identify, document, and communicate compliance observations promptly.
• Track and trend quality observations to support site performance metrics.
• Initiate and document minor non-conformance events.
• Support Return to Service activities and associated quality documentation.
• Review utility alarms, maintenance records, and calibration documentation.
• Assist with SOP revisions and GMP-controlled documents.
• Support investigations, deviations, corrective actions, and change control.
• Collaborate with Manufacturing, Quality, Engineering and cross-functional teams.
• Maintain accurate records in accordance with GMP and GDP requirements.
• Follow safety policies, procedures and regulatory standards.

Skills

GMP knowledge

Quality oversight

Documentation review

Inspection

Cross-functional collaboration

Microsoft Office

Education

College degree preferred

Tools

MS Office

Job description

Kedrion Biopharma Inc. in Melville, NY is seeking a GMP Quality Associate for an overnight 06:00 pm – 06:00 am shift on site.

You will work on the production floor with Manufacturing and Quality teams to oversee daily operations, review documentation, and help resolve quality issues in real time. This role emphasizes compliance with GMP and GDP, attention to detail, and continuous improvement in a highly regulated environment.