Overnight GMP Quality Associate – Manufacturing

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

Job summary

Kedrion Biopharma Inc. is seeking a Manufacturing Quality Associate for an overnight shift (6:00 pm – 6:00 am) in Melville, NY. The role emphasizes quality, compliance, and hands-on work on the production floor within a GMP-regulated environment.

The position requires a college degree or equivalent experience and prefers knowledge of GMP/GDP, pharma manufacturing, and documentation review. Employment is onsite with benefits and a competitive hourly pay range.

Qualifications

• Knowledge of GMP and GDP regulations in a regulated pharma environment.
• Experience in pharmaceutical manufacturing, Quality or Operations environment.
• Ability to interpret manufacturing documentation, batch records, logbooks, and compliance records.

Responsibilities

• Monitor batch processing to ensure compliance with procedures, batch records, and cGMP.
• Conduct routine inspections of operations, equipment, systems, utilities, and facilities.
• Perform in-process quality oversight on the production floor and support real-time resolution of issues.
• Review production logbooks and batch records for critical parameter verification.
• Support plasma and component inspection activities to ensure product quality and compliance.
• Track and analyze observations to support site quality metrics and KPIs.
• Initiate and document minor non-conformance reports and quality investigations.

Skills

GMP knowledge

GDP knowledge

Pharmaceutical manufacturing

Documentation review

Education

College degree preferred

Job description

Kedrion Biopharma Inc. is seeking a Manufacturing Quality Associate for an overnight shift (6:00 pm – 6:00 am) in Melville, NY. The role emphasizes quality, compliance, and hands-on work on the production floor within a GMP-regulated environment.

The position requires a college degree or equivalent experience and prefers knowledge of GMP/GDP, pharma manufacturing, and documentation review. Employment is onsite with benefits and a competitive hourly pay range.