- Eisai, Inc (Raleigh, NC)
- …from you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai ... .Familiarity with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to… more
- Merck & Co. (Rahway, NJ)
- …. - Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply related topics ... and senior leaders.- - Works directly in the SAP system to establish a consolidated , visible forecast for...relationship management. - Technical Proficiency: familiarity with supply chain systems and software ( eg SAP or Oracle) and… more
- Merck & Co. (Rahway, NJ)
- …Clinical Trial Operations (GCTO) Regional colleagues and Global Development Quality (GDQ) to address clinical supply related topics.-Responsible and accountable ... assigned studies such as IRT & Microsoft PowerApps. -Works directly in the SAP system to ensure a robust and consolidated forecast for CFGs is maintained. --Report… more
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …validation, and data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation, process validation, equipment, ... equipment used at the site.Develops and evaluates quality processes and system standards to ensure compliance with applicable Legend standards, industry… more
- Novo Nordisk Inc. (West Lebanon, IN)
- … while collaborating with the Engineering team to provide necessary documentation, quality system interaction, and performing a variety of highly diverse ... compliance , risk management, and use of current technology System Design and Specification Contribute to design and specify...software Work with PM to support the commission the system , ensuring all devices and systems are… more
- Aequor (Hicksville, OH)
- Packager - Support Specialist 2nd shift Packaging = /hr pay rate rd Shift Packaging = /hr pay rateImportant that they are able to work on the 1st shift (6:45 am - ... feedback on operator performance. Interacts with production management, mechanics, and Quality Assurance. Participates in training of new employees. Adheres to all… more
- Merck & Co. (Rahway, NJ)
- …Standard Operating Procedures (SOP) and current GXP documents.Experience with quality systems .Excellent organizational skills.Desire and willingness to learn, ... Rahway, New Jersey.The Sterile Process Engineer role at the Senior Specialist level will leverage the individual's leadership, technical, and communication skillsets… more
- Twist BioScience (South San Francisco, CA)
- …including Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems ... The Regulatory Operations Specialist is responsible for ensuring the efficient and...SOP's. This role is crucial in supporting global product compliance , ensuring that all documentation accurately reflects regulatory requirements… more
- Daher (Charleston, SC)
- …ensure the highest standards of quality and safety. We're currently seeking a Logistics Quality & Compliance Specialist to join our growing team. In this ... customer expectations Job description Your Mission As the Logistics Quality & Compliance Specialist ,...you'll serve as a subject-matter expert in aviation logistics quality systems . You'll lead audits, monitor processes… more
- Merck & Co. (Durham, NC)
- …DescriptionJoin our dynamic Engineering, Maintenance, & Utility Department as a Senior Specialist , where you will play a crucial role in enhancing asset reliability ... leadership skills to empower teams, solve complex technical challenges, and ensure compliance with industry standards while making a tangible impact on our… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and instructional systems design preferred Knowledge of pharmaceutical manufacturing quality system , including knowledge of FDA requirements preferred Strong ... Competence) Drive implementation of Training for Competence and training compliance at site Ensure local system and...required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you!The Associate Specialist , Calibration is a member of the Engineering, Maintenance and Site Services ... sites.- This includes Energy Center, Vaccine Bulk and Manufacturing Facilities, Quality Labs, Material Management Storage Facility (MMSF) and projects. At times,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , is a member of the Site Automation team responsible for the assigned process control systems in support of manufacturing ... of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations.- Actively support,… more
- Cepheid (Miami, FL)
- …about the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for supporting quality systems ... and decisions on product development activities to ensure continued compliance with internal procedures and applicable US FDA, EU...be a plus if you also possess previous experience in: Quality Systems / Quality Engineering background in… more
- Catalent, Inc. (Kansas City, MO)
- … Assurance Senior Specialist . The Supplier Quality Assurance Senior Specialist will assure compliance to national and international standards by managing ... Supplier Quality Assurance Senior Specialist Position Summary...committed to a Patient First culture through excellence in quality and compliance , and to the safety… more
- Actalent (Charlotte, NC)
- …5 years of construction management experience. Experience establishing and maintaining effective quality control systems in compliance with contract ... Job Title: Quality Control Specialist *Per diem available...implementation of audit protocols. Audit third-party vendors to ensure quality and compliance . Create weekly reports to… more
- Veterans Health Administration (Los Angeles, CA)
- …Laboratory Information Manager, Quality Manager, Laboratory Manager, Regional Technical Specialist , National Quality and Compliance Agent, Regional ... Specialist ) for the Greater Los Angeles VA Healthcare System . This is an OPEN CONTINUOUS ANNOUNCEMENT and will...analyzer specialist , primary operator on new test systems , quality control specialist , supply… more
- BioSpace (Homestead, PA)
- …and shifting priorities in support of changing company objectives Understand Quality Systems and/or regulated training requirements Working Conditions (physical ... are adhered in order to support the operations and quality requirements for business operations. Reporting compliance ...being used Collaborates with center management when viewing the Quality Management System to identify, coordinate and… more
- Katalyst HealthCares and Life Sciences (Rensselaer, NY)
- …provide guidance through all stages of the quality management system and improvement projects. Ensures new systems /processes/procedures are compliant with ... Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron's Quality System requirements. Participate and support the Quality Risk… more
