Quality Assurance Analyst
Kedrion Biopharma Inc.
Melville, NY 11747$22 - $24 an hour
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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
Quality Assurance Analyst performs routine inspections of production activities. The Analyst 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 Analyst monitors batch processing activities for their compliance with the established procedures, batch records and cGMP requirements:
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 Analyst 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
If assigned, the QA Analyst 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.
Qualifications and need-to-know
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.
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: 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 [email protected].
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.
Job Summary
Quality Assurance Analyst performs routine inspections of production activities. The Analyst 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 Analyst monitors batch processing activities for their compliance with the established procedures, batch records and cGMP requirements:
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 Analyst 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
If assigned, the QA Analyst 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.
Qualifications and need-to-know
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.
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: 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 [email protected].
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.