Quality Control Support Coordinator

Kedrion Biopharma GmbH; Melville (NY); On-site; USD 34,440 - 38,572; 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 GmbH in Melville is seeking a Quality Control Support Coordinator to enhance compliance and operational efficiency in a dynamic lab environment. The role involves managing sample lifecycle, overseeing equipment calibration, and ensuring adherence to cGMP standards.

The ideal candidate will possess a Bachelor’s degree in relevant fields, strong organizational and communication skills, and familiarity with SAP systems.

Kedrion offers a competitive salary plus benefits including medical, vision, dental insurance, and paid holidays.

Qualifications

• Bachelor’s degree in microbiology, chemistry, life sciences, or related field.
• Preferred experience in a GMP-regulated environment.
• Experience in the pharmaceutical industry preferred.

Responsibilities

• Manage sample lifecycle activities including receipt, storage, tracking, and disposal.
• Support test scheduling activities such as bioburden and stability testing.
• Ensure compliance with cGMP standards.

Skills

Organizational skills

Communication skills

Attention to detail

Microsoft Office Suite proficiency

Education

Bachelor’s degree in microbiology, chemistry, life sciences, or related field

Tools

SAP systems

Job description

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

Take the lead in supporting quality excellence—drive compliance, precision, and operational efficiency in a dynamic lab environment. As a Quality Control Support Coordinator, you will play a key role in maintaining Quality Control operations by performing a blend of technical and administrative functions. Working closely with QC laboratory teams, you will help ensure compliance with cGMP standards while managing laboratory processes such as sample handling, documentation, and equipment coordination. This role requires strong organizational skills, attention to detail, and the ability to collaborate across cross-functional teams to uphold quality and compliance standards.

What you’ll do

• Manage sample lifecycle activities including receipt, storage, tracking, and disposal.
• Support test scheduling activities such as bioburden and stability testing.
• Maintain stability programs by managing sample storage conditions and ensuring adherence to testing timelines.
• Enter and maintain stability data in systems such as Novatek and logbooks.
• Coordinate equipment maintenance and calibration schedules for laboratory instruments (e.g., pipettes, balances, pH meters, refrigerators, freezers).
• Respond to equipment alarms and initiate appropriate follow‑up actions.
• Submit and track work orders related to laboratory equipment and facilities.
• Monitor BAS data loggers for laboratory equipment and environmental conditions on a regular basis.
• Create purchase requests and manage incoming materials and reagent storage.
• Coordinate sample and reagent shipments in collaboration with warehouse teams.
• Verify accuracy and compliance of QC documentation and distribute to appropriate departments (e.g., QA, Operations).
• Support documentation archiving processes and maintain laboratory logbooks.
• Draft general QC SOPs and submit for managerial review.
• Assist with training documentation and tracking for laboratory personnel.
• Support laboratory readiness for internal and external audits and inspections.
• Collaborate with team members on process improvements and quality initiatives.
• Communicate quality or compliance concerns promptly and effectively.
• Assist with data collection and entry across laboratory systems as needed.
• Participate in additional laboratory support activities and cross‑functional projects as assigned.
• Support laboratory documentation review including, laboratory function support, data verification, inventory management etc.

Qualifications and need‑to‑know

• Bachelor’s degree in microbiology, chemistry, life sciences, or related field.
• Experience working in a GMP‑regulated environment preferred.
• Experience in the pharmaceutical industry preferred.
• Familiarity with SAP systems preferred.
• Strong administrative and organizational skills.
• Effective written, verbal, and interpersonal communication skills.
• Proficiency in Microsoft Office Suite.
• Knowledge of Lean Six Sigma tools or methodologies preferred.
• Ability to comply with applicable safety, environmental, and regulatory requirements.
• Willingness to complete required hazardous waste and safety training as applicable.

Pay Range: $25.00–$28.00

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. 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!

If you would like further details regarding the benefits we offer, we can provide you with our full benefits guide and answer 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 [e-mail].

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.