Kedrion Biopharma Inc.
Manufacturing QA Associate - DAYS 6am-6pm, incl. weekends
Kedrion Biopharma Inc., Melville, New York, us, 11775
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 Quality Assurance (MQA) Associate performs routine inspections of production activities. The Associate is available on the Operations floor working together with other MQAs and Operations departments to ensure compliance issues are detected and solved in real time. The Associate performs in-process reviews of production batch record and logbooks.
Main Responsibilities:
The MQA Associate 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.
The MQA Associate helps with:
Return to Service Actions
Review of critical systems/utilities Alarms
Work Order /Preventative Maintenance Review
Calibration Record Review
If assigned, the MQA Associate 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.
The MQA Associate follows and promotes organizational safety policy.
Knowledge, Skills, and Abilities:
Focus on delivering excellent customer service.
GMP and strong quality culture oriented individual.
Able to communicate both verbal and written.
Problem solving skills, results oriented.
Experience with pharmaceutical investigation plus.
Knowledge of Microsoft Office and e-mail required.
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.
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 upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.
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.
Manufacturing Quality Assurance (MQA) Associate performs routine inspections of production activities. The Associate is available on the Operations floor working together with other MQAs and Operations departments to ensure compliance issues are detected and solved in real time. The Associate performs in-process reviews of production batch record and logbooks.
Main Responsibilities:
The MQA Associate 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.
The MQA Associate helps with:
Return to Service Actions
Review of critical systems/utilities Alarms
Work Order /Preventative Maintenance Review
Calibration Record Review
If assigned, the MQA Associate 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.
The MQA Associate follows and promotes organizational safety policy.
Knowledge, Skills, and Abilities:
Focus on delivering excellent customer service.
GMP and strong quality culture oriented individual.
Able to communicate both verbal and written.
Problem solving skills, results oriented.
Experience with pharmaceutical investigation plus.
Knowledge of Microsoft Office and e-mail required.
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.
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 upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the personnel training requirements of the NYSDEC.
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.