- Legend Biotech USA, Inc. (Raritan, NJ)
- …position is responsible for performing a wide range of activities to support the release of drug products for human use. This position is responsible for quality and ... responsible for drug product batch record review and drug product release practices.Develop positive relationships with the QA team, Quality Control, Information… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Analytical Chemist I will provide analytical testing to support ongoing product release , raw material release and stability studies as needed, generate, ... and review technical documents that support raw material and product release and stability, will be responsible for managing activities with good time management to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Analytical Chemist II will perform analytical testing to support ongoing product release , raw material release and stability studies as needed, generate, ... and review technical documents that support raw material and product release and stability under minimal supervision, and will be responsible for managing their… more
- Merck & Co. (Rahway, NJ)
- …quality notices, CAPA management as the business area representative, as well as release and stability programs. This position is in Rahway, NJ, and will foster ... Our BAR&D GMP Operations team validates analytical methods and performs release and stability testing for biologic therapies in clinical development, impacting… more
- Merck & Co. (Durham, NC)
- …associated with the development and implementation of assays for product release , quality lab qualifications and method verification efforts Actively participate on ... support and subject matter expertise support to ongoing quality laboratory release activities. Support management and submission of samples to support commercial… more
- Merck & Co. (Rahway, NJ)
- …help prioritize the backlog, drive the operations resources and coordinate release /testing activities including coordination of the testing team. - - Major ... for execution, and focus on reducing impact early and often. - Drive release and operational support planning and execution - Serve as primary contact point… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to support business needs such as raw material, in-process, method transfer, release , and/or stability testing.Reviews and approves documents to release of ... components, raw materials and drug products.Provides troubleshooting support as neededPerformance and documentation of laboratory investigationsInternal auditing and handling of external audits by customers and FDA during departmental reviewPurchase equipment… more
- Twist BioScience (South San Francisco, CA)
- …leverage new software features.Support Software UsersWork with teams to define post- release software issuesWork with internal software teams to resolve software ... record of successful software releases including validation, user training, post- release issue definition and resolution.Understanding of database design and SQL… more
- Genmab (Plainsboro, NJ)
- …to expand, focusing on Application Engineering, Application Development and Release Automation Engineering to achieve Architectural and Engineering excellence. This ... to expand, focusing on Application Engineering, Application Development and Release Automation Engineering.RequirementsExperience in Life Sciences, Biotech or Pharma… more
- Merck & Co. (Rahway, NJ)
- …work in applying regulatory guidance and quality standards related to product release and safety.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - ... Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have… more
- Merck & Co. (Durham, NC)
- …a team of individual contributors responsible for the environmental monitoring and routine release testing of BCG at the Teknika site in Durham, North Carolina.- ... Additional duties will include support of site business processes, such as change control, deviation management, audits and regulatory inspections.- The Manager will be responsible for using principles of our Company Production Systems, Lean Laboratories, and… more
- Merck & Co. (Durham, NC)
- …of 6 months in a quality function that supports compliance, release and/or environmental monitoring supporting a GMP manufacturing facility/ utilities. Previous ... environmental monitoring experience in a clean room environment. The candidate must possess highly developed communication and teamwork skills. Proficiency in Microsoft applications (Excel, Word, PowerPoint, Power Apps) Applies team effectiveness skills,… more
- Aequor (Salt Lake City, UT)
- …satisfied for raw materials, labeling materials, and packaging materials prior to release . This position is responsible for artwork review and approval, retain ... management and label issuance as needed to support operations. ESSENTIAL AREAS OF RESPONSIBILITY All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …QC IRMI Technician is responsible for performing QA inspection, sampling, AQL, and release labeling of raw materials to be used in production. Job Responsibilities ... API raw materialsPerform inspections and sampling required for retest folders Apply release labels to raw materials upon final disposition Escalates any internal… more
- Merck & Co. (Rahway, NJ)
- …which includes estimation and supporting refinement of storiesExecute on defined release strategy for the platformResponsible for documentation of all procedures to ... support the development, deployment and use of the platformDesign, Development and Testing of proposed enhancements to ServiceNowProvide tier 3 (engineering level) support for operations of the platform for ServiceNow.Coordination of Problem Investigations… more
- Merck & Co. (Durham, NC)
- …Executes and manages Operations batch record review within established timelines for release and effectively liaisons with Quality to resolve comments in a timely ... manner Day shift Operations representative for various site needs (Quality Assessments, Process Simulation support, etc.) Leads/Supports production and quality projects and process system improvements Lead problem-solving of real-time shop floor issues Support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Drug Products, Stability and Microbiology testing. Data Review may include release , raw material, and stability data and laboratory notebooks. Additionally, the ... reviewer will need to ensure that all activities are performed in compliance with cGDP, cGLP and cGMP requirements.Job ResponsibilitiesReview logbooks for daily, monthly, quarterly, and final Quality Review.Review and approve Particle Matter, Helium Leak,… more
- BioAgilytix (San Diego, CA)
- …services for biologics and cell and gene therapies.Experience selling full release method development, validation and stability programs for biologics and ATMPs ... is preferred. Proven track record in closing deals and driving significant top line revenueAbility to build relationships through professional sales and interpersonal skills with a disciplined and organized approachDemonstrated entrepreneurial work… more
- Merck & Co. (Rahway, NJ)
- …V Recipes, and material BOMs - . Deploying manufacturing and associated release standards in compliance with the company's Quality Manual and collaborating with ... network partners for a common approach. Developing future breakthrough business solutions, initially leveraging existing resources in the company's network to reduce overall effort and risk and optimizing these solutions to facilitate rapid product launch.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …a strong project management office to enable robust production, testing and release of product to patients.Key Responsibilities Helps to develop and support ... implementation of a project management office (PMO) with tools such as project portfolio management to prioritize projects to deliver improved business performance and increase utilization and skills of plant team membersLeads generation and alignment of… more
