- Kedrion Biopharma (Melville, NY)
- …and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, developing, and implementing ... in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion serves as SME (Subject… more
- Curia (Rensselaer, NY)
- …the Curia Quality team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior ... Quality Control and Manufacturing computerized systems + Generate and execute validation documents, to ensure the system (s)/software are maintained in the… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews and aids in developing… more
- Cornerstone onDemand (New York, NY)
- …& Validation ) lifecycle for Cornerstone's validated SaaS Learning Management System (LMS), which is deployed to customers in heavily regulated industries. You ... Banking, Manufacturing, Healthcare, and Government and ensures that our software systems meet both functional specifications and intended use for our regulated… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple ... + Proficient in using Microsoft Office applications (Word, Excel, Outlook) and validation database systems . + Ability to work collaboratively with… more
- Unither Pharmaceuticals (Rochester, NY)
- …the Validation Document Library, maintains test equipment and documentation system . ESSENTIAL FUNCTIONS / RESPONSIBILITIES: Assists in the execution of ... products and surface swabbing for testing as outlined by validation /qualification protocols. Maintains protocols and system documentation in… more
- Stantec (Albany, NY)
- …stored in GMP conditions and distributed, including computerized and automated systems which require qualification and validation for compliance. The ... commissioning and validation of equipment, facilities, utility systems and computerized systems are intended to verify that they are designed, installed,… more
- Regeneron Pharmaceuticals (Troy, NY)
- … validation data to FDA and other regulatory agencies. + Maintaining validation document and software control system while ensuring that validation ... At Regeneron, we are seeking a Manager, QA (Internal Validation Oversight) to lead a team dedicated to ensuring...a team dedicated to ensuring the integrity of our validation processes. In this role, you will be responsible… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- The QA Validation department is hiring! The Principal QA Validation Specialist validates and qualifies equipment, systems , and processes in accordance with ... and implement company manufacturing standards policies and procedures. + **Fill Finish Validation :** this team will work multi-functional with all areas of the… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- … Fill Finish team is hiring a Manager! As the Manager, QA Validation you will validate/qualify equipment, systems , and processes related to cleaning, ... sterilization, and Aseptic Process Simulation Validation in accordance with regulatory requirements and support, follow and implement company manufacturing standards… more
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