- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Specialist, Quality Assurance is accountable for review and approval of documentation to support Good Manufacturing Practice (GMP) clinical ... communications with all stakeholders in all manufacturing operations, analytical testing, quality assurance , regulatory, etc. at all levels.Establish, educate,… more
- Merck & Co. (Rahway, NJ)
- …Product Commercialization, Project Leadership, Project Procurement Management, Project Risk Assessments, Quality Assurance Processes, Quality Assurance ... and technical personnel and interacting with their functional equivalents in Quality Disposition and Pharmaceutical Research and Development and, Procurement… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites ... GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing,… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. Director, Clinical Quality Assurance The Director, Clinical Quality Assurance position is ... in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of...delivery and execution of the North America (NA) Clinical Quality Assurance (CQA) strategy including audit and… more
- Aequor (Thousand Oaks, CA)
- …Ideal Candidate: See top 3 skillsets. 4-5 YOE is preferred. In support of 's Quality Assurance program manages and oversees the operations of a specific area(s) ... using multiple sources of information (eg, Qualitative information, Quantitative research , Trend data) 7. Anticipates and prevents potential problems 8.… more
- Merck & Co. (Rahway, NJ)
- …Final Study Report Maintain contact with all stakeholders (project leader, regulatory affairs, quality assurance etc.) and keeps them informed of the study ... progress.May be the Global Clinical Research (GCR) representative in the project team. Assume responsibility for certain monitoring and data management tasks (eg,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the ... implementation of a quality strategy and quality plan closely aligned...quality oversight of marketed products in collaboration with Research QA, PV QA, CSPV and other internal QA… more
- Merck & Co. (Durham, NC)
- …with Cost Reporting, Schedule Development and EstimatingEarly project planningConstruction Quality Assurance and ControlFamiliarity with union labor and ... Material(s):n/aRequired Skills:Applied Engineering, Capital Management, Construction, Construction Management, Construction Quality Assurance , Cost Management, Decision Making, Global… more
- Merck & Co. (Rahway, NJ)
- …with partners in other functional lines, such as Drug Safety and Metabolism, Quality Assurance , and program management, under the supervision of management ... Intrapersonal Communication, Laboratory Safety, Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmacokinetics, Quality Assurance (QA), Reverse Phase Chromatography-Preferred Skills:Job… more
- Merck & Co. (North Wales, PA)
- …management conceptsExperience in CDISC and ADaM standardsDemonstrated success in the assurance of deliverable quality and process compliance.Strategic thinking - ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...project plans are executed efficiently with timely and high quality deliverables.For assigned projects the position serves as the… more
- Merck & Co. (North Wales, PA)
- …requirements - ** Preferred Skills and Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong working knowledge ... Job DescriptionIn BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our...project plans are executed efficiently with timely and high quality deliverables. - For assigned projects the position serves… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance . Overall accountability is develop strategic framework work for ... providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders....at least 5 plus years of experience within progressive GxP- Quality Assurance or equivalentMust have a minimum… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Confirm final profile and submit in Zycus for SAP creation.As relevant, liaise with the Quality Assurance group to obtain QA risk rating and audit status for RDP ... up-to-date evaluations. Review and update questions and pending statuses with the Quality Assurance group on a regular basis.Qualifications Successful candidates… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Biologic, and Vaccine Products. Our team works with a "Safety First, Quality Always" mindset.-As the primary point of contact for all dealings between… more
- Merck & Co. (Rahway, NJ)
- …Mechanical Apptitude, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmaceutical Quality Assurance , Process Technologies, Production Efficiencies, ... GMP (Good Manufacturing Practices) manufacturing facility in the Small Molecule Process Research and Development (SM PR&D) organization. The SSO pilot plant enables… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Digital Transformation (DX) strategy, regulatory compliance framework, and overall quality assurance standards. This role collaborates with cross-functional ... focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. SummaryThe Regulated… more
- Merck & Co. (North Wales, PA)
- …available through commercial software packages required.Must have demonstrated success in the assurance of deliverable quality and process compliance and possess ... Job Description Primary Activities :Provide high quality statistical programming analysis and reporting deliverables for global stakeholders in Early Development… more
- Tris Pharma (Monmouth Junction, NJ)
- …contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with GxP and other company and ... across organization to ensure continuity of supply while optimizing cost, quality and delivery for internal and external stakeholder satisfactionCollaborates cross… more
- Merck & Co. (Rahway, NJ)
- …are a leading pharmaceutical company committed to improving health through innovative research , development and production of medicines. With a strong emphasis on ... papers (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of… more
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