GMP Quality Associate (Overnight Role 06:00 pm - 06:00 am)

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

Career Opportunities: GMP Quality Associate (Overnight Role 06:00 pm - 06:00 am) (4855)

Kedrion Biopharma Inc. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for us in treating and preventing serious diseases, disorders and conditions such as Hemophilia, Primary Immune System Deficiencies and Rh-Sensitization.

Job Summary

Be at the forefront of quality and compliance in pharmaceutical manufacturing.

The GMP Quality Associate supports quality oversight activities across manufacturing operations to help ensure products are manufactured safely, consistently, and in compliance with regulatory requirements. Working directly on the production floor, this role partners with Manufacturing and Quality teams to monitor operations, review documentation, perform routine inspections, and help resolve quality issues in real time. This is an excellent opportunity for individuals who are passionate about quality, compliance, and continuous improvement in a highly regulated environment.

What you'll do

• 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.

Qualifications and need-to-know

• College degree preferred or equivalent combination of education and relevant experience required.
• 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.

Employment eligibility verification will be required at the time of hire. This position does not offer visa sponsorship now or in the future.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Kedrion Biopharma Inc. is committed to providing equal employment opportunities to all employees and applicants. We prohibit discrimination and harassment based on race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all employment terms, including recruitment, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Please note that salary ranges are calculated based off levels of: relevant experience, education, and certifications.

Kedrion Biopharma Inc. offers numerous benefits to our qualifying employees, including:

• Medical, vision and dental insurance
• Life and AD&D insurance
• Paid holidays
• PTO accrual
• and much more!

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.