Overnight GMP Quality Specialist – On-the-Floor QA

Kedrion Biopharma Inc.; Melville (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, vision and dental insurance

Life and AD&D insurance

Paid holidays

PTO accrual

Job summary

Kedrion Biopharma Inc. is seeking a GMP Quality Associate for the overnight shift (6:00 pm – 6:00 am) to provide quality oversight on the production floor and ensure compliance with cGMP and GDP requirements.

The role involves reviewing batch records, inspecting facilities, supporting investigations, and collaborating with cross-functional teams to drive continuous improvement in a highly regulated manufacturing environment.

Qualifications

• College degree preferred or equivalent combination of education and relevant experience.
• Experience in pharmaceutical manufacturing, Quality Assurance, Quality Operations, or production environments 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 investigations, deviations, non-conformances, or quality systems is preferred.
• Strong attention to detail and ability to review technical documentation accurately.
• Effective verbal and written communication skills.
• Demonstrated problem-solving and organizational abilities.
• Proficiency with Microsoft Office applications and email systems.
• Ability to work effectively in a team-oriented manufacturing environment.
• Commitment to safety, quality, regulatory compliance, and continuous improvement.

Responsibilities

• Provide quality oversight and GMP support for daily manufacturing operations.
• Monitor batch processing activities to ensure compliance with approved procedures, batch records, and cGMP requirements.
• Conduct routine inspections of production activities, manufacturing areas, utilities, systems, and facilities.
• Review production logbooks, batch records, and supporting documentation for completeness, accuracy, and compliance.
• Verify critical manufacturing parameters and support in-process quality reviews.
• Support plasma and component inspection activities.
• Identify, document, and communicate compliance observations and quality concerns in a timely manner.
• Track and trend quality observations to support site performance metrics and continuous improvement initiatives.
• Initiate and document minor non-conformance events.
• Support Return to Service activities and associated quality documentation.
• Review utility alarms, maintenance records, work orders, and calibration documentation to ensure compliance requirements are met.
• Assist with the revision and maintenance of SOPs and other GMP-controlled documents.
• Support investigations, deviations, corrective actions, and change control activities as assigned.
• Collaborate with Manufacturing, Quality, Engineering, and other cross‑functional teams to support operational excellence.
• Maintain accurate records and documentation in accordance with GMP and GDP requirements.
• Follow all safety policies, procedures, and regulatory standards.
• Perform additional duties and project work as required to support site objectives.

Skills

Quality oversight

GMP knowledge

Detail orientation

Effective communication

Education

Bachelor's degree or equivalent

Tools

MS Office

Job description

Kedrion Biopharma Inc. is seeking a GMP Quality Associate for the overnight shift (6:00 pm – 6:00 am) to provide quality oversight on the production floor and ensure compliance with cGMP and GDP requirements.

The role involves reviewing batch records, inspecting facilities, supporting investigations, and collaborating with cross-functional teams to drive continuous improvement in a highly regulated manufacturing environment.