Kedrion Biopharma Inc. is an international company specializing in the collection and fractionation of blood plasma to produce and distribute plasma-derived therapeutic products. Our therapies help treat and prevent serious diseases, including Hemophilia, Primary Immune System Deficiencies, and Rh-Sensitization.
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.
Salary ranges are determined based on relevant experience, education, and certifications.
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.
Employee Benefits
At Kedrion Biopharma Inc., we believe in taking care of our people. Our benefits package is designed to support your health, happiness, and future, including:
- Health & Wellness – Full medical, dental, and vision coverage
- Financial Security – Life insurance, AD&D, and retirement savings plans
- Work-Life Balance – Paid time off, sick leave, and paid holidays
- Career Growth – Training programs and development opportunities
- Extra Perks – Employee discounts, wellness initiatives, and more!
For specific inquiries please reach out to us
Job Summary
Quality Assurance Associate I performs routine inspections of production activities. The Associate is available on the Operations floor working together with other QAs and Operations departments to ensure compliance issues are detected and solved in real time. The Associate performs in-process reviews of production logbooks and supports plasma, and component inspections
What you'll do
- The QA Associate I monitors batch processing activities for their compliance with the established procedures, batch records and cGMP requirements:
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- Routine inspections and documentation of Operations floor activities, systems, utilities, and facilities as per the checklists.
- Routine review of logbooks and Batch records including the confirmation of Critical Parameters.
- Line clearances as per Operations schedule.
- Oversight and AQL syringe inspection, packaging, approval of incoming plasma, raw material, and printed component inspections.
- The QA Associate I can perform:
- Interventions
- Minor Non-conformance Initiation/writing
- Pest Control
- SOP revisions
- Return to Service Actions
- Review of critical systems/utilities Alarms
- Work Order /Preventative Maintenance Review
- Calibration Record Review
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If assigned, the QA Associate I participates in departmental and interdepartmental teamwork and performs other tasks or assignments as directed by the QA Supervisor/Manager. This may include writing deviations, performing investigations, writing change controls, and executing action items, revising SOPs and other GMP documents.
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The QA Associate I follows and promotes organizational safety policy.
Qualifications and need-to-know
Requirements
- College degree or equivalent education preferred /Equivalent experience required.
- Pharmaceutical experience in Quality or Operations department preferred.
- Experience with biologics Quality Assurance or Operations plus.
- Plasma fractionation, aseptic filling, and labeling experience plus.
- GMP and strong quality culture oriented individual.
- Able to communicate both verbal and written.
- Knowledge of Microsoft Office and e-mail required.
Working Conditions
- Primarily inside with well-lighted and well-ventilated areas.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained. In lieu of HAZWOPER training, the employee will receive training on the requirements of the New York State hazardous waste management regulations pursuant to 6 NYCRR §373-3.2. All employees that have received the above mentioned training within the first six months of hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.
Work Schedule: Monday- Friday 8:00am- 4:30pm
Pay Range: $23.00- $24.00/HR
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.