- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on ... including Safety Data Sheets (SDS), SOP, and work instructions Familiarity with Quality Management Systems and electronic document control systems … more
- Merck & Co. (Rahway, NJ)
- …supplies . - Interacts with key partner organizations such as clinical development, regulatory , quality and other supply chain areas to address clinical supply ... 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
- Aequor (Thousand Oaks, CA)
- …Drug Product Formulation and Vial/Syringe Filling operations Experience with various quality systems including change control, deviations, corrective and ... to peers and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across… more
- Aequor (Hicksville, OH)
- …employees. Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and… 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 ... of BMS hardware and software Work with PM to support the commission the system , ensuring all devices and systems are correctly connected and functional Work… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the Quality team based in Raritan, NJ.… 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
- Abbott (Maple Grove, MN)
- …with diabetes from routine fingersticks. The Opportunity We are looking for our next Senior Regulatory Quality Specialist to join our team on-site out of our ... Maple Grove, or St. Paul, MN locations. This Regulatory Quality Senior Specialist position...the GRS department. With limited supervision, coordinates and compiles regulatory procedures/processes and leads Regulatory systems… 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 ... make our products. We work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work in the local plant… 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 ... databases required Knowledgeable in GMP processes, Quality Management System (QMS), & standard improvement systems preferred Demonstrated expertise… 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
- Twist BioScience (South San Francisco, CA)
- …sessions, as needed.Each Twist employee is responsible for complying with applicable Quality Management System (QMS)/Information Security Management System ... The Scientific Technical Support Specialist will be responsible for providing best in...their daily activities and ensuring product or service meets regulatory requirements, customer requirements and the established QMS/ISMS policies… more
- EBR Systems, Inc. (Sunnyvale, CA)
- …IEC 62304, RoHS) and apply them across sustaining activities. Support audit readiness, regulatory inspections, and quality system improvements tied to ... The Regulatory Affairs Specialist or Senior ...Quality , Supply Chain, and Sustaining Engineering to ensure regulatory compliance and global market access. The position is… more
- Katalyst HealthCares and Life Sciences (Magna, UT)
- … Assurance, and other associates on compliance support activities Understands fundamental global regulatory and quality system requirements Stays informed of ... systems to Regulatory Affairs team Provides regulatory support for internal and external quality ...Provides regulatory support for internal and external quality system audits Supports development and implementation… more
- Planet Pharma (Lake Forest, CA)
- … requirements and adherence to internal policies and processes. Provides high quality regulatory support for assigned products/projects. Develops documents that ... necessary. Willing to obtain notary license in California. Compile and maintain regulatory documentation databases or systems . Coordinate efforts associated with… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- …standards. General understanding of product development process, design control and quality system regulations. General understanding of regulations applicable ... The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support...changes for compliance with applicable regulations. Support and maintain Quality initiatives in accordance with BSC Quality … more
- Meta (Burlingame, CA)
- …Affairs and other functions at all levels within the business Drive improvement in regulatory aspects of the Quality System , developing processes and ... documenting procedures to ensure an effective Quality System Review and approve marketing, advertising, promotional items and labeling for regulatory … more
- Advancial Federal Credit Union (Dallas, TX)
- …the company's affirmative action plan, please complete this form. SUMMARY The Regulatory Reporting Financial Specialist is responsible for compiling, analyzing, ... mission is to create lasting value for our members through superior service, quality products, and innovative solutions. At Advancial, we always strive to provide… more
- RESILIENCE (West Chester, OH)
- …in need. For more information, please visit www.resilience.com Position Summary: The Senior Specialist , Technical Quality will play a pivotal role in ensuring ... technology transfer, ensuring adherence to established specifications, procedures, and regulatory requirements. Provide quality oversight, review, and approval… more
- MemorialCare (Fountain Valley, CA)
- …an emphasis on behavioral health. General knowledge of health care delivery systems and regulatory requirements. Proficiency in computer and software utilization ... Description Title: LMFT, Behavioral Health Specialist Location: Fountain Valley Department: Behavioral Health Program Status: Full-time Shift: Day Pay Range*:… more
