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
Make an impact where quality meets life‑saving science. As a Quality Associate for a high performing manufacturing facility, you’ll play a critical role on the manufacturing floor—ensuring compliance, accuracy, and real‑time resolution of quality issues that directly support the safety and effectiveness of plasma‑derived therapies. Partnering closely with Operations and QA teams, you’ll help uphold strict regulatory standards while contributing to continuous improvement in a highly regulated environment.
What you'll do
- Monitor batch processing activities to ensure adherence to procedures, batch records, and cGMP requirements
- Perform routine inspections of production floor activities, including systems, utilities, and facilities, following established checklists
- Review logbooks and batch records, confirming accuracy and critical process parameters
- Execute line clearances in accordance with the production schedule
- Oversee and support AQL syringe inspections, packaging processes, and approval of incoming plasma, raw materials, and printed components
- Work on the operations floor to proactively identify and help resolve compliance issues in real time
- Initiate and document minor non‑conformances and support corrective actions as needed
- Perform interventions such as return‑to‑service activities, pest control support, and SOP revisions
- Review critical systems and utilities alarms, preventive maintenance records, work orders, and calibration documentation
- Collaborate with QA and cross‑functional teams to maintain compliance and operational readiness
- Participate in departmental and interdepartmental initiatives as assigned by QA leadership
- Support deviation investigations, change control activities, and execution of corrective and preventive actions
- Assist in maintaining and updating GMP documentation and supporting continuous improvement efforts across quality systems
Qualifications and need-to-know
- College degree or equivalent experience required
- Experience in a pharmaceutical Quality Assurance or Operations environment preferred
- Exposure to biologics manufacturing or Quality Assurance is a plus
- Experience with plasma fractionation, aseptic filling, or labeling processes is an asset
Work Schedule: Thursday-Monday 8:00am-4:30pm (Including weekends)
Pay Range: $22.00- $24.00/HR
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.