- Merck & Co. (Rahway, NJ)
- …of the Compliance Support and Remediation team within our company's Global Quality Compliance Support organization.- The responsibility of this position crosses all ... sites and global GMP SMEs.-Job Function:serve as a subject matter expert for good manufacturing practices (GMP) for drug products, active pharmaceutical… more
- Aequor (Swiftwater, MN)
- …markets. The position is based in Swiftwater, PA USA. This is a hybrid position. Mission The Regulatory CMC Specialist in Regulatory Site Office supports regulatory ... maintenance and site registrations. The incumbent also ensures the role of regulatory expert for regulatory topics and projects at the Swiftwater and Pearl River… more
- Merck & Co. (Rahway, NJ)
- …to ensure optimal trial design and monitoring of studies, producing high- quality clinical documents and presentations. The position requires a solid understanding ... Clinical DevelopmentMay serve as a senior therapeutic area content expert within the company, providing input into research and...under California, Colorado and other US State Acts US Hybrid Work Model Effective September 5, 2023, employees in… more
- Merck & Co. (Durham, NC)
- …our patients. We work in the manufacturing plants with a "Safety First, Quality Always" mindset, striving for continuous improvement, and earn our right to produce. ... local plants connected to our global manufacturing network supplying the highest quality of raw materials, intermediates, and finished products.This role is within a… more
- Merck & Co. (Durham, NC)
- …nonconforming material from stock, place in quarantine and notify Quality Inspector of non-conformance.Pick material based on transfer request requirements ... material in SAP via Inventory Transaction Entry.Coordinate with purchasing and/or quality on receivables that are inaccurate or nonconforming according to Purchase… more
- Merck & Co. (Durham, NC)
- …Remove nonconforming material from stock, place in quarantine and notify Quality Inspector of non-conformance. Pick material based on transfer request requirements ... material in SAP via Inventory Transaction Entry. Coordinate with purchasing and/or quality on receivables that are inaccurate or nonconforming according to Purchase… more
- Merck & Co. (Durham, NC)
- …but are not limited to:Project SupportSupports project team as operations expert through start-up, commissioning, qualification through licensure and ramp up of ... 5S, kaizen events, or any other operations, lean six-sigma, quality , safety or environmental training/initiatives as required.Operational ExpertiseCompetent execution… more
- Merck & Co. (Rahway, NJ)
- …Excellence. The role also involves strategic partnering with Development Quality , Process Research & Development, Pharmaceutical Operations, and other parts ... of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include:...key partner groups or serving as a subject matter expert during GxP audits and inspections. Fostering strong collaborations… more
- Merck & Co. (South San Francisco, CA)
- …Key Responsibilities:Serve as a project-team representative and DMPK subject matter expert for biologics drug discovery and development, including but not limited ... selection, and drive PK/PD translationBe accountable for providing timely and high- quality data to teamsAuthor regulatory documents from FIH through registrational… more
- Merck & Co. (Boston, MA)
- …position, your primary roles will include:Project-team representative and subject matter expert on small molecule and/or peptide-based DMPK activities within the ... communication, problem solving and collaborative qualities to deliver high quality results in a fast-paced environmentPreferred Experience and SkillsHands-on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relationship with key stakeholders and senior management within Finance, Legal, IT, Quality , Compliance and Product Safety. Leads an Operations team comprising up to ... KPIs, while delivering on the objectives of process agility, quality output, strong collaboration, and high productivity from team...Physical Requirements 0-10% overnight travel required. This is a hybrid role requiring 3 days per week onsite in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team to help identify true root cause of investigations and assess product quality impact. This individual will provide technical support to the investigators and ... aimed at improving compliance and reducing repeat occurrences ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …campaign operations. Serve as an NNI interface with vendors who provide expert staff, managing contracting and budgeting. Partner closely to set vendor management ... of Omnichannel CX Operations to establish KPIs, SLAs, and quality standards for campaign execution and cost management. Define...process swim lanes, project plan templates, etc.) Physical Requirements Hybrid Model: 3 days in office, 2 days remote.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives requiring MES enhancements.Coordinate MES ... with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build the Site Readiness of MES for FDA… more
- Eisai, Inc (Nutley, NJ)
- …managing global initiatives and matrixed resources, as well as direct reports. Expert knowledge of industry standard frameworks and best practices - ISO ... NJ, USA; or Hatfield, UK.Open plan office environment, on a hybrid basis.Qualifications and Experience:Advanced degree in Technology or Business highly… more
- Aequor (South San Francisco, CA)
- Job Title : Contract Associate II Location : South San Francisco, CA (This role is hybrid and must be onsite in SSF Monday- Thursday but can work remote on Friday) ... as-needed basis. The Associate is expected to be an expert in the process of supporting both full-service and...contracts with AORs and media agencies and serves a quality check to drive accuracy in reporting vis a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …appropriate challenging, development, feedback, regular recognition, and support Physical Requirements Hybrid policy: 3 days in office and 2 days remote. ... customer experiences is required Proven success in developing strategy through expert understanding of market and industry Ability to manage complexity, including… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on strategies to maximize effectiveness and efficiency over time Physical Requirements Hybrid policy: 3 days in office, 2 days remote. Approximately 20-30% overnight ... and market dynamics preferred Proven success in developing strategy through expert understanding of market and industry Ability to manage complexity, including… more
- Elevance Health (San Juan, PR)
- **Operations Expert ** **Location:** ** Hybrid (Candidates must live within commutable distance of the San Juan, PR Pulse Point: 654 Avenue Luis Munoz Rivera, San ... Inc. a leading health company dedicated to improving the quality of life of communities in the United States....they serve more than 118 million people._ The **Operations Expert ** is responsible for providing technical direction, guidance and… more
- Jacobs (Pittsburgh, PA)
- …enable the heart of our clients' businesses. You may be an expert Process Engineer, Project Manager, Manufacturing Engineer, Equipment/Mechanical Design Engineer or ... needs into an appropriate scope of work and serve as subject matter expert (SME) during proposal presentations. * Mentor and train colleagues on current… more
