- 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
- Eisai, Inc (Raleigh, NC)
- …with applicable regulatory requirements (eg, FDA, EMA, ICH) and quality systems .Strong oral and written communication skills.Strong attention to detail ... you. The QA Specialist plays a critical role in ensuring the quality and compliance of commercial and clinical products manufactured at the Eisai Raleigh… 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
- 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
- Masimo (Irvine, CA)
- …in project meetings and provide regulatory guidance; Update RA responsible quality system procedures as required (SQP/SOP's); Performs other duties or ... Description Job Summary In this high profile role, the Regulatory Affairs Specialist I will be an...Experience with FDA/GMP requirements for medical device; Experience in Quality Systems , per ISO 13485; Experience with… more
- Atrium Medical (Hudson, NH)
- …changes through RA/QA practices by documentating the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and ... domestic, and international compliance activities working under the direction of the Regulatory Affairs Director. Assists the Regulatory Affairs Director with … more
- VB Spine LLC (Allendale, NJ)
- Regulatory Labeling Specialist Location : Leesburg, VA or Allendale, NJ (Hybrid) Company : VB Spine Looking for a career where your work truly matters? At VB ... and grow in a dynamic, fast-paced environment. As a Regulatory Labeling Specialist , you'll support compliant product... audits Ensure all documentation aligns with VB Spine's Quality Management System and Good Documentation Practices… more
- CryoLife (Kennesaw, GA)
- …quality procedures to ensure quality system compliance and high- quality work. Maintain and update regulatory processes and SOPs as directed. Provide ... regulatory or compliance activities under management direction. Support general quality system programs (CAPAs, NCRs, internal/external audits, PMS, Risk… more
- Intuitive (Sunnyvale, CA)
- …world of minimally invasive care. Job Description Primary Function of Position This RA Specialist will play a key role in managing China RA regulatory ... (PLE), and other cross-functional supporting teams to ensure the company's regulatory affairs activities are conducted in accordance with company policies and… more
- BioSpace (Homestead, PA)
- …and shifting priorities in support of changing company objectives Understand Quality Systems and/or regulated training requirements Working Conditions (physical ... ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to...being used Collaborates with center management when viewing the Quality Management System to identify, coordinate and… more
- SUNSHINE ENTERPRISE USA LLC (Orange, CA)
- Job Description Grievance & Appeals Nurse Specialist At Sunshine Enterprise USA, we're not just a company; we're a community of dedicated professionals committed to ... current job opportunities below. Job Title: Grievance & Appeals Nurse Specialist Department(s): Grievance and Appeals Resolution Services (GARS) Reports to: Manager… 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
