- Merck & Co. (Durham, NC)
- …harvest, lyophilization, product inspection, and quality control laboratories. The Quality Assurance Specialist will support this expansion. Project activities ... Job DescriptionOur Quality Assurance group ensures all materials inside our products...triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This… more
- Merck & Co. (Ames, IA)
- …attending and presenting in prominent industry scientific meetings.Deliver a high level of technical expertise, service and support to our Company's Animal ... in (IA, SD, MN) and is responsible for providing technical support to Sales and Marketing for...services are provided within corporate objectives and within budget guidelines. Technical service includes but is not limited… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing operations ... in the development of process, operational, and quality improvements for manufacturing Support manufacturing and technical operations teams in trouble shooting… more
- Merck & Co. (North Wales, PA)
- …to remediate risks as appropriate.- Ensure that facilities/processes are compliant and support approval of new modality regulatory filings.our Technical CMC ... products to global markets, to serve our patients. This leader will support the implementation, including change management actions, of the new organization to… more
- Catalent (St. Petersburg, FL)
- …SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's St. Petersburg site. The ... Release, and Change Control.The QA Product Manager provides customer service , with the highest integrity, focused on quality and...QA Product Manager is responsible for the overall Quality Assurance review and approval of all technical … more
- Merck & Co. (North Wales, PA)
- …for study data standard deliverables and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and ... teamwork and collaborationExcellent written and verbal, and presentation skills; effective technical writing, able to convert complex ideas and information into… more
- Merck & Co. (North Wales, PA)
- …clinical trials to world-wide regulatory application submissions and post marketing support .The incumbent is responsible for the design and maintenance of ... statistical databases that support multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key… more
- Merck & Co. (North Wales, PA)
- …our company IT Data hub and Supplier's environment.-Among key responsibilities are: TECHNICAL ENABLEMENT: Provides critical support in establishing technical ... Tool (SMART) and others if needed- and the Supplier system) in order to support generation of- study KRIs and Quality Tolerance Limits (QTL)s out of Supplier… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …network and other manufacturing systems. This position provides Tier 2 and 3 support , technical recommendations and direction, and coordinate technical ... Support Tier 2 and 3, including projects support : Documents, tracks and monitors the IT service...delivery and Incident response) IT Infrastructure SME for Quality assurance / GMP and Validation: Maintain qualified state of… more
- Merck & Co. (Rahway, NJ)
- …is an essential component of the current IT division that provides support to the Pharmaceutical Research and Development (R&D), Supply Chain (Manufacturing), ... of the associated enterprise assets, and cost-effective delivery of capabilities to support achievement of immediate and future state business objectives. Within the… more
- BioAgilytix (Durham, NC)
- …a critical part of our beginning-to-end client data quality processes. Through your technical reviews of raw and processed data, you will ensure data integrity ... workflows. You are the bridge between the lab and the quality assurance team, combining observations on regulatory requirements with your knowledge of plate-based… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and under the appropriate storage conditions. Make appropriate quality decisions in support of warehouse activities. Ensure that cycle counts are accurate and ... in accordance with the procedures. Review and inspect documentation in support of Final Product Shipments. Generates inspection reports and non-conformances for… more
- Aequor (Seattle, WA)
- …control experience in a cGMP/FDA regulated environment. Strong communication and customer service skills. Some technical writing skill set including the ability ... Document Control & Reporting Experience, - Veeva experience preferred - Technical troubleshooting - Self motivated, independent, great communication - Experience… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team setting with quality counterparts that include Manufacturing Operations, Operations Technical Support , Maintenance, Supply Chain and Planning Requirements A ... over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile...of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required A minimum of 4 years… more
- Merck & Co. (North Wales, PA)
- …mentoring and coaching to Sr. Scientist and Assoc Principle scientist in support of their assigned projects. Position Description- The Principal Scientist / Director ... in product in-license/due diligence review, product divestment and product withdrawal. Support new technology development.Demonstrate an understanding of regulatory affairs… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the quality systems processes within a cell therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This ... (cGMP). Manage multiple and complex cross-functional projects with many stakeholders. Support other quality systems activities, as needed. Support drafting,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in meetings with quality counterparts that include Manufacturing Operations, Operations Technical Support , Maintenance, Supply Chain and Planning. Approve the ... over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile...of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required. A minimum of 5 years… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …The Director of Quality Operations , CAR-T is responsible for Quality oversight and support of c ell therapy manufacturing operations , in full complianc e with ... final drug product, QA shop floor oversight of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others .… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …working experience in an aseptic manufacturing facility, preferablyin quality assurance , manufacturing compliance, clinical quality, technical operations or ... providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …level position with responsibilities for leading deviations and corrective actions in support of the QC testing laboratories related to the manufacturing of cell ... collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, and Analytical/Process Development. Job duties performed… more
