Software Quality Operations Associate Jobs in Fort Lee, NJ

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

Help ensure quality, compliance, and operational excellence in pharmaceutical manufacturing.

The Quality Operations Associate plays a critical role in supporting quality operations within a GMP-regulated manufacturing environment. Working directly on the production floor, this position partners with Manufacturing and Quality teams to monitor production activities, perform routine inspections, review documentation, and identify compliance issues in real time. This role is ideal for individuals looking to build their quality career while contributing to the production of life-changing therapies in a highly regulated industry.

What you'll do

• 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.

Daytime Role: 06:00 am - 06:00 pm (Alternating days including weekends)

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 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.

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.

This policy applies to all terms and conditions of employment, including recruiting, 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!

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have!

If you require assistance with your employment application or need reasonable accommodations to perform job duties, please contact our Talent Acquisition team at kedtalent@kedrion.com .

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.