Kedrion Biopharma is a biopharmaceutical company specializing in the development, production and distribution of plasma-derived products. Kedrion has been producing plasma products for over 40 years and has a market presence in about 100 countries. Our employees are committed to the highest standards and therapies for the patients and clinicians in hematology, immunology, neurology, and transfusion medicine.
Quality Operations and Manufacturing Associate I performs routine inspections of production activities. The Associate is available on the Operations floor working together with other Quality and Operations departments to ensure compliance issues are detected and solved in real time. The Associate I performs in-process reviews of production logbooks and supports plasma, and component inspections.
Main Responsibilities:
The Quality Operations and Manufacturing Associate I monitors batch processing activities for their compliance with the established procedures and cGMP requirements and performs:
o Routine inspections and documentation of Operations floor activities, systems, utilities, and facilities as per the checklists.
o Routine review of logbooks and batch records including the confirmation of Critical Parameters and to ensure documentation is maintained with the Good Documentation Practices and Data Integrity requirements.
o Line clearances as per Operations schedule.
o Support AQL syringe inspection and packaging inspections.
o Support and approval of incoming plasma, raw material, and printed component inspections.
The QA Associate I can perform:
o Minor Non-conformance initiation and writing
o Pest Control, HEPA and other certification report reviews
o Minor SOP revisions
o Return to Service actions plan initiation and documentation management
o Review of BAS critical systems/utilities alarm reports
o Work Order /Preventative Maintenance review
o Calibration record review
If assigned, the Associate I participates in departmental and interdepartmental teamwork and performs other tasks or assignments as directed by the Manager. This may include writing deviations,
performing investigations, executing action items, revising SOPs and other GMP documents.
The Associate I follows and promotes organizational safety policy.
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.
Kedrion Biopharma offers a number of benefits to 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!
Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.
Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.
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