Manufacturing Quality Associate

Kedrion Biopharma • Melville, NY • 3h ago

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 and compliance at every stage of pharmaceutical manufacturing.

The Quality Operations and Manufacturing Associate I plays a key role in supporting manufacturing quality and compliance activities within a GMP-regulated pharmaceutical environment. Working directly on the production floor, this position partners with Quality Assurance and Operations teams to monitor manufacturing activities, perform routine inspections, review documentation, and identify compliance issues in real time. This role is ideal for individuals who are passionate about quality, operational excellence, and maintaining the highest standards in pharmaceutical manufacturing.

What you'll do

Monitor batch processing activities to ensure compliance with approved procedures, batch records, and current Good Manufacturing Practices (cGMP).

Conduct routine inspections of manufacturing operations, equipment, systems, utilities, and facilities using established checklists.

Perform in-process quality oversight on the production floor and support real-time resolution of compliance-related issues.

Review production logbooks and batch records, including verification of critical manufacturing parameters.

Support plasma and component inspection activities to ensure product quality and compliance.

Track, document, trend, and analyze operational observations to support site quality metrics and key performance indicators.

Initiate and document minor non-conformance reports.

Support Return to Service activities and related quality documentation.

Review critical system and utility alarms for compliance and operational impact.

Review work orders, preventive maintenance documentation, and calibration records to verify compliance requirements.

Assist with the revision and maintenance of Standard Operating Procedures (SOPs) and GMP documentation.

Participate in cross-functional and departmental initiatives focused on continuous improvement and quality performance.

Support quality investigations, deviation management activities, change controls, corrective actions, and other quality systems as assigned.

Maintain accurate and timely documentation in accordance with GMP and GDP requirements.

Promote and follow all site safety policies, procedures, and regulatory requirements.

Collaborate effectively with Quality, Manufacturing, Engineering, and other operational teams to support manufacturing readiness and compliance.

Perform additional duties and assignments as required to support business and operational needs.

Qualifications and need-to-know

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

Experience within a pharmaceutical manufacturing, Quality, or Operations environment preferred.

Experience supporting biologics manufacturing, Quality Assurance, or manufacturing 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 preferred.

Experience with pharmaceutical investigations, deviations, or quality systems is a plus.

Ability to review and interpret manufacturing documentation, batch records, logbooks, and compliance records.

Strong written and verbal communication skills.

Demonstrated problem-solving skills and attention to detail.

Proficiency with Microsoft Office applications and email systems.

Ability to work effectively in a team-oriented manufacturing environment.

Commitment to following safety procedures, company policies, and applicable regulatory requirements.

Ability to complete required training and perform responsibilities in accordance with approved SOPs and quality standards.

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.

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