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.
Manufacturing Technician I and II is responsible for the compliant execution of the manufacturing process strictly adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. Under the general direction of the supervisor, this position shall be responsible for the hands-on execution of all activities in the production area. Activities include manual tasks and operation of automated equipment. In addition to making routine revisions to documents, technician may rewrite complex procedures or initiate new procedures as applicable.
The RhoGAM Fill/ Finish Production Coordinator will be responsible for the compliant execution of SAP transactions, order production components, materials, and assist with investigations /deviations related to RhoGAM fill finish department inclusive of Filling, Syringe inspections and Packaging. The coordinator will be required to support the production floor operation as needed.
The Coordinator will be responsible for the request of all required documentation from QA to perform production. In addition, thew coordinator will review and close out all documentation and deliver to QA in a timely manner for release.
The individual is expected to ensure all relevant documentation and reports involving the change are accurate, compliant, and timely, adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. In addition to making routine revisions to documents, The Production Coordinator may rewrite procedures or initiate new procedures as applicable. The person will work on the shop floor when needed to support production.
Main Responsibilities Perform all tasks required of a RhoGAM Fill/ Finish Operator.
Perform all process order transactions in SAP for RhoGAM filling, Manual syringe inspection, and Packaging.
Perform all logbook, batch record and other department related document reviews and close out upon the completion of all production batches and deliver the documentation to QA in a timely manner for review.
Request all logbooks, batch record and other department related documents from QA in a timely manner.
Assist with investigations /deviations related to RhoGAM fill finish department inclusive of Filling, Syringe inspections, Packaging and Hemin production.
Participate in the creation, review and revision of Standard Operating Procedures and other manufacturing-related documents related to the department.
Ensure compliance with all regulations that impact the manufacturing operations.
Assure adequate inventory of production and cleaning supplies are maintained daily by monitoring and managing proper levels of inventory through SAP.
Adhere to safety/EHS requirements, SOPs, cGMP, work rules and other company policies.
May be responsible for the delivery of final container samples to the respective laboratories.
May perform other duties as assigned.
Education, Qualifications, and Experience - High School Diploma or GED. College degree preferred in Biology or related.
- Knowledgeable in SAP and TrackWise and Master ControlControl Systems preferred.
- Must be flexible, able to work extended hours (overtime), and alongside multiple departments.
- Good written and verbal communication skills.
- Team player and builder.
- Self-motivator.
- Good math skills and ability to perform calculations as per batch record.
- Computer literacy and proficiency with Microsoft Office and e-mail a plus.
- Sufficient technical competence to organize and lead production activities.
- Problem solving skills and results oriented.
- Ability to Multi-task Assignments.
- Ability to operate a computer using Microsoft.
Physical Requirements: Ability to stand/walk more than 75% of scheduled work time.
Ability to handle chemicals with proper PPE (Respirator) for buffer solutions.
Ability to work extended hours up to 17 hours if required.
Ability to gown into coveralls or scrubs.
Ability to work in a 2 to 8C cold room for a minimum of 1+ hour.
Ability to walk up and down stairs more than 5 feet high, more than 5x/day.
Ability to clean rooms, equipment and parts during the shift.
Ability to bend, stoop or kneel.
Ability to lift, tug, push and pull up to fifty (50) pounds.
Ability to wear required respirator.
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.