Quality Operations Specialist - GMP Floor Support

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

Many more benefits

Job summary

Kedrion Biopharma Inc. in Melville, NY seeks a Quality Operations Associate for a daytime shift (06:00 am – 06:00 pm) onsite. You will support quality operations on the production floor, review documentation, and monitor manufacturing activities to uphold GMP and GDP compliance.

The role requires attention to detail, teamwork, and effective communication as you partner with Manufacturing and Quality to ensure product quality and regulatory readiness. Prior pharma experience is preferred.

Qualifications

• College degree preferred or equivalent combination of education and relevant experience required.
• Experience in pharmaceutical manufacturing, Quality Assurance, Quality Operations, or manufacturing operations preferred.
• Knowledge of GMP and GDP regulations and experience working in a regulated environment.
• Experience with biologics manufacturing, plasma fractionation, aseptic filling, or labeling operations is a plus.
• Experience supporting quality investigations, deviations, non-conformances, or quality systems is preferred.
• Strong attention to detail and ability to review technical and manufacturing documentation accurately.
• Effective written and verbal communication skills.
• Demonstrated problem-solving, organizational, and analytical abilities.
• Proficiency with Microsoft Office applications and email systems.
• Ability to work collaboratively in a team-oriented manufacturing environment.
• Commitment to safety, quality, compliance, and continuous improvement.
• Ability to complete required training and follow approved procedures, SOPs, and company policies.

Responsibilities

• Provide on-floor quality support for manufacturing operations and production activities.
• Monitor batch processing activities to ensure compliance with approved procedures, batch records, and cGMP requirements.
• Conduct routine inspections of manufacturing areas, equipment, systems, utilities, and facilities using established quality checklists.
• Review production logbooks, batch records, and related documentation for accuracy, completeness, and compliance.
• Verify critical process parameters and support in-process quality reviews throughout manufacturing operations.
• Support plasma and component inspection activities to help ensure product quality and compliance requirements are met.
• Identify, document, and communicate quality observations and compliance concerns in a timely manner.
• Track and trend documentation observations to support site quality metrics and continuous improvement initiatives.
• Initiate and document minor non-conformance reports and support related follow-up activities.
• Review work orders, preventive maintenance records, calibration records, and utility alarms to ensure compliance with quality standards.
• Support Return to Service activities and associated quality documentation requirements.
• Assist with the revision and maintenance of Standard Operating Procedures (SOPs) and GMP-controlled documents.
• Participate in investigations, deviations, change controls, corrective actions, and other quality system activities as assigned.
• Collaborate with cross-functional teams to support manufacturing readiness, operational efficiency, and compliance objectives.
• Maintain accurate and timely documentation in accordance with GMP and GDP requirements.
• Follow all safety policies, procedures, and regulatory requirements while promoting a strong quality culture throughout the organization.
• Perform additional duties and project assignments as needed to support site operations and business objectives.

Skills

GMP knowledge

GDP knowledge

Documentation review

Team collaboration

Attention to detail

Communication skills

Problem-solving

MS Office

Education

College degree

Job description

Kedrion Biopharma Inc. in Melville, NY seeks a Quality Operations Associate for a daytime shift (06:00 am – 06:00 pm) onsite. You will support quality operations on the production floor, review documentation, and monitor manufacturing activities to uphold GMP and GDP compliance.

The role requires attention to detail, teamwork, and effective communication as you partner with Manufacturing and Quality to ensure product quality and regulatory readiness. Prior pharma experience is preferred.