Onsite GMP Quality Assurance Associate, Day Shift

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

Job summary

Kedrion Biopharma Inc. is seeking a Quality Assurance Associate for a daytime shift in Melville, NY. On the manufacturing floor, you will provide QA support, review batch records, ensure compliance with GMP/GDP, and collaborate with Quality and Operations teams to uphold product quality.

The role emphasizes real-time observations, documentation, and involvement in deviations, investigations, and change controls while maintaining strict safety and regulatory standards.

Qualifications

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

Responsibilities

• Provide on-floor quality support for manufacturing operations within a GMP-regulated environment.
• Monitor batch processing activities to ensure compliance with approved procedures, batch records, and cGMP requirements.
• Conduct routine inspections of production areas, equipment, systems, utilities, and facilities using established checklists.
• Review production logbooks and batch records, including verification of critical process parameters.
• Support plasma and component inspection activities as required.
• Identify, document, and communicate quality observations in real time to support operational compliance.
• Track and trend documentation observations to support site quality metrics and continuous improvement initiatives.
• Initiate and document minor non-conformance reports.
• Support Return to Service activities and associated quality documentation.
• Review critical system and utility alarms to assess compliance and operational impact.
• Perform reviews of work orders, preventive maintenance records, and calibration documentation.
• Assist with the development, revision, and maintenance of SOPs and other GMP-controlled documents.
• Participate in cross-functional projects and departmental initiatives to support quality and operational excellence.
• Support investigations, deviations, change controls, corrective actions, and other quality system activities as assigned.
• Maintain accurate, complete, and timely documentation in accordance with GMP and GDP requirements.
• Adhere to all company safety policies, procedures, and regulatory standards.
• Collaborate effectively with Manufacturing, Quality Assurance, Engineering, and other functional teams.
• Perform additional duties and assignments as needed to support site operations.

Skills

Quality Assurance

GMP knowledge

Attention to detail

Communication skills

Team collaboration

Problem solving

Training compliance

Education

Bachelor’s degree (preferred)

Tools

Microsoft Office

Email systems

Job description

Kedrion Biopharma Inc. is seeking a Quality Assurance Associate for a daytime shift in Melville, NY. On the manufacturing floor, you will provide QA support, review batch records, ensure compliance with GMP/GDP, and collaborate with Quality and Operations teams to uphold product quality.

The role emphasizes real-time observations, documentation, and involvement in deviations, investigations, and change controls while maintaining strict safety and regulatory standards.