- Catalent (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release , and Change Control.II. Basic Function: This position is ... in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing...verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions… more
- United Therapeutics (Eden Prairie, MN)
- …to help patients with liver and kidney disease. How you'll contribute The Senior QA Specialist - GMP Manufacturing, is responsible for supporting quality ... operations during GMP clinical manufacturing of bioengineered organs at Miromatrix. The Senior QA Specialist collaborates with and provides support for… more
- Bristol Myers Squibb (Summit, NJ)
- …science, your career, and the ability to help patients are incredible. The ** Senior Specialist , Sr. Manufacturing Systems Engineer, MS&T MSEO** is responsible ... product impact assessments to support change management, investigations, and product release . + Develop inputs into electronic batch record/process automation… more
- Novo Nordisk (Clayton, NC)
- …& handled in close collaboration with production. Main duties include review of batch reports & release of API materials, deviations, change controls, review ... spot checks of validation documentation + Perform activities related to Batch review & release + Review & approve API/Intermediate Batch documentation in… more
- Bristol Myers Squibb (Bothell, WA)
- …oversight extends across the entire product lifecycle, encompassing manufacturing, batch release , investigations, customer feedback management, document control, ... streamlined digital processes to meticulously affirm control. The QC Senior Specialist , Assay Trainer will support the...On the Job Training for QC Assays and material release procedures (Immunoassay, PCR, Flow Cytometry, Raw Material, and/or… more
- BioBridge Global (San Antonio, TX)
- …Range: Hourly $25.40-$30.00/ Annually $52,832.00- $62,400.00** Job Title: Product Compliance Senior Specialist Revision: 0000 Job Code: 703729 Shift: Monday- ... compliance requirements. Knowledge of all tasks performed by Product Compliance Specialist . Donor Packet Evaluation to include donor deferrals, recalls, cosignee… more
- Hovione (East Windsor, NJ)
- …Control, Deviations, Quality agreements, Qualification and Validation, Stability Programs, Batch Release , Equipment Cleaning, Client Audits, Internal Audits, ... age, gender, religion, disability, sexual orientation or ethnicity. (https://en-careers-hovione.icims.com/jobs/10062/ senior -quality-assurance- specialist /job?mode=apply&apply=yes&in\_iframe=1&hashed=-1834418400) Hiring Request Post Information* :… more
- Cardinal Health (Rochester, NY)
- …disposition documentation in a timely manner, such as: manufacturing batch records, EM records, validation documentation, change controls, process qualifications, ... **Accountabilities** + Handles CGMP documentation review related to product release , facilities and equipment, material controls, laboratory controls, packaging and… more
- Bristol Myers Squibb (Summit, NJ)
- …product impact assessments to support change management, investigations, and product release . + Develop inputs into electronic batch record/process automation ... your career, and the ability to help patients are incredible. The ** Specialist , Manufacturing Systems Engineer , MS&T MSEO** is responsible for supporting the… more
- Novo Nordisk (Clayton, NC)
- …Novo Nordisk and help us make what matters. The Position Ensures plant systems batch release & other relevant quality processes are compliant with regulations ... Has product release authority (Authorized Qualified Person), if role is in batch release . Serve as Quality oversight, review & approval of validation… more
- Kedrion Biopharma, Inc. (Melville, NY)
- …in hematology, immunology, neurology, and transfusion medicine. The Quality Operations Specialist has a robust understanding of applicable CGMP regulations and ... role is responsible for ensuring that all aspects of product release meet analytical, manufacturing production, specifications in accordance with established quality… more
- Novo Nordisk (Clayton, NC)
- …Nordisk and help us make what matters. The Position Ensures plant systems batch release , and/or relevant quality processes are compliant with regulations. Has ... product release authority, if role is in batch release . Quality oversight, review & approval...Trends and reports data as applicable. Relationships Reports to Senior (Sr.) Manager, QA. Essential Functions + Make decisions… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release , and Change Control. **II. Basic Function:** This position ... in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing...verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions… more
- Waystar (Atlanta, GA)
- …team is also responsible for building and managing the core system logic to batch payment data and integrate with the banking system for funding and accounting. The ... we are looking for an outstanding, brilliant, and driven Specialist Application Engineer to join our growing team. While...requirements + Communicates the development progress daily to the senior -level team members + Attends to any work items… more
