- Merck & Co. (Durham, NC)
- …active ingredient, finished product, and laboratory testing for the BCG vaccine.The Senior Specialist , Quality Control participates in a team of analysts in the ... assay validation, equipment validation, and GMP laboratory readiness.- The Senior Specialist , Quality Control will be responsible for starting testing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of final packaging materials for product launch. This individual also supports the systems and processes by which regulatory labeling items are created, approved ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and accessible Enters and monitors project and data in Regulatory Label Management systems (LIFT, SPL, ALiCE,… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , Quality Control participates in a team of analysts in the development, validation, and routine testing intermediate and ... final product samples. The Quality Operations Laboratory Specialist performs laboratory testing...have a strong understanding of Labware Laboratory Information Management System (LIMS), handle Quality Notification authoring and… more
- Aequor (Thousand Oaks, CA)
- …positions available - admin hours 8-5 Mon - Friday. Ideal candidate: Experience with quality management systems and 5&plus YOE. Nice to have: Veeva knowledge. Ex ... QUALIFICATIONS? 5 years of biopharmaceutical experience responsibility in a quality , analytical development, process development, pharmaceutics, regulatory , or… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Associate Specialist , Quality Operations (QO) is accountable for maintaining regulatory compliance for the Environmental Monitoring (EM) ... program. The role will require working closely with Quality , Technical, Operations, and IT organizations at the local...- Job Description: Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases. Execute… more
- Aequor (Thousand Oaks, CA)
- … engineers Previous experience managing implementation of Quality Management System Requirements, Product Standards / Regulatory Requirements (eg FDA CFRs ... Senior Specialist QA Remote any time zone OK Does...prioritiesPreferred Qualifications: Strong Knowledge and experience in Medical Device Quality System Regulations and Medical Device Standards… more
- Twist BioScience (South San Francisco, CA)
- …production processes, project management, Supply Chain andWarehouse Management, Validation, and Quality Systems . Prior experience supporting other peripheral ... data governance processes for Twist Operations toensure a high quality of data throughout all systems where...quality . Identify and maintain data ownership at the system , business function, or process levelas well at an… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …communication skillscGMP manufacturingMaintenance, facilities and utilitiesComputerized maintenance management systems (CMMS)EHS and regulatory standards (eg ... treatment of multiple myeloma.Legend Biotech is seeking an Maintenance Specialist I (2nd or 3rd shift) as part of...position will be responsible for maintenance support and mechanical system operations for cGMP Clinical and Commercial Cell Therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and support and track all process improvement projects.Key Responsibilities Support all quality system records (ie CAPA's and change controls) to ensure ... of multiple myeloma.Legend Biotech is seeking QC Microbiology Technical Specialist I/II/III as part of the Quality ...tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Other duties will… more
- Merck & Co. (Durham, NC)
- …work at the shop floor level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes ... Quality Assessments, Process Simulation support, etc.) Leads/Supports production and quality projects and process system improvements Lead problem-solving of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- LA Care Health Plan (Los Angeles, CA)
- Regulatory Compliance Quality Audit Specialist Job Category: Customer Service Department: CSC Appeals & Grievances Location: Los Angeles, CA, US, 90017 ... effectively with diverse team members. Ability to formulate recommendations to improve quality and service delivery, and develop effective system and process… more
- ProMedica Health System (Toledo, OH)
- …acts as a role model and resource to the healthcare team by enhancing safety and quality care. The regulatory specialist assists the team to understand and ... The regulatory specialist supervises all aspects of...as-needed basis across the organization. 8. Investigates payer and regulatory quality of care concerns and guides… more
- Actalent (Lake Zurich, IL)
- …may be considered) + Attention to Detail + Strong Communication Skills + Strong Computer/ Quality Systems and Regulatory Systems Experience (RegTrack) ... Regulatory / Quality Compliance SpecialistResponsibilities + Manage product...and Labeling groups for compliance with annual reports and regulatory submissions. + Utilize RegTrack system for… more
- MyFlorida (Tallahassee, FL)
- …Division of Medical Quality Assurance Board of Nursing Regulatory Specialist II Salary $33,760.00/annually Open Competitive Opportunity Your ... REGULATORY SPECIALIST II - 64005441 Date: Jan 7, 2025 The State Personnel System is an E-Verify employer. For more information click on our E-Verify Website… more
- University of Pennsylvania (Philadelphia, PA)
- …Contingent upon funding. The CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to participate in the ... Assurance Lead, the Veeva Quality Assurance Specialist will review, itemize and migrate all regulatory... Specialist will review, itemize and migrate all regulatory documentation from the current document management system… more
- Omnicell (Pittsburgh, PA)
- **Product Regulatory Specialist II ( Quality Assurance Engineer II)** Reporting to the Manager of Product Regulatory and located at the Omnicell Cranberry ... Woods, PA or Fort Worth, TX facility. The Quality and Regulatory Engineer will be responsible...medical device experience. + Experience working with complex electro-mechanical systems . + Experience with global regulatory requirements… more
- System One (Stamford, CT)
- Job Title: Regulatory Affairs Specialist 10883 Location: Stamford, CT (Onsite) Shift: M-F, 8am - 5 pm Type: Contract 1 year Pay: $30-32.50/hour Must Haves: * ... regulatory compliance. Develop and implement robust data management systems to track changes and updates in regulations. *...get work done more efficiently and economically, without compromising quality . System One not only serves as… more
- Methodist Health System (Dallas, TX)
- …**Days Of Week :** M-F **Work Shift :** **Job Description :** Your Job: The Regulatory Specialist will perform expertise in the regulatory component of all ... investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, vision, values, and… more
- System One (Trumbull, CT)
- Job Title: Regulatory Affairs Specialist 10882 Location: Trumbull CT Type: Contract 11 months (onsite) Shift: M-F, 8 am - 5pm Pay: $32 - 35.85/hour depending ... related field, preferred * Minimum of one year of regulatory experience, preferably in Consumer Packaged Goods * Familiarity...get work done more efficiently and economically, without compromising quality . System One not only serves as… more
