- 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)
- …your career, and the ability to help patients are incredible. The ** Specialist , Senior Technical Writer** will collaborate with internal Manufacturing partners, ... T manufacturing operations including SOPs and Work Instructions. The Senior Associate shall review manufacturing batch records...leading and closing Root Cause Analysis to support lot release . + Some knowledge with CAPAs and Change Controls.… 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
- 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 (Indianapolis, IN)
- **_What a Sr. Specialist , QC Microbiology contributes to Cardinal Health:_** Quality develops and implements quality policies, procedures, and processes to ensure ... + Perform various microbiological testing procedures adhering to Manufacturing/QC batch records, protocols, and/or test methods. + Perform environmental monitoring… 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
- 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...in Department. Trends and reports data as applicable. Relationships Senior Manager, Quality Assurance. 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
- Gilead Sciences, Inc. (Foster City, CA)
- …Description** **Role and Responsibilities:** + Review and approve master batch records, labels, specifications and other pre-production documents for ... and international health agency requirements. + Review executed production batch records, environmental monitoring data (as required), and associated documentation,… more
- Novo Nordisk (Clayton, NC)
- …Team Novo Nordisk and help us make what matters. The Position Ensure Batch Production Records (BPRs) & relevant quality processes are compliant with regulations and ... associated corporate and local standard operating procedures (SOPs) Release of raw materials. Quality oversight, review & approval of validation activities associated… more
