- GRAIL (Durham, NC)
- …. As part of the Compliance, Operations, Records, and Education (CORE) organization, the Quality Systems Specialist will be responsible for supporting the ... support for internal and external audits and inspections. + Assist the Quality Systems Software Business Owner/SME with validation and configuration… more
- Terumo Medical Corporation (Elkton, MD)
- Sr. Quality Systems Documentation Specialist Date: Oct 15, 2025 Req ID: 5082 Location: Elkton, MD, US Company: Terumo Medical Corporation Department: ... go next!** **_Advancing healthcare with heart_** **Job Summary** The Senior Quality Systems Documentation Specialist will be responsible for developing,… more
- Kerry (Sturtevant, WI)
- …Sturtevant, WI 53177. What You'll Do 1st Shift is 8 am to 4 pm. Overview The Quality Systems Specialist supports the Quality and Food Safety Management ... key part in internal audits, documentation, and continuous improvement initiatives. The Quality Systems Specialist collaborates with cross-functional teams… more
- Aequor (Thousand Oaks, CA)
- Senior Specialist QA Remote any time zone OK Benefit but not required: local to Thousand Oaks, CA Ideal Candidate: Looking for QA experience (not QC) and 5&plus ... Does the thought of building an entirely new digital quality management system, excite you? Do you love to...that support the Digital QMS Maintain knowledge of current systems , tools, standard methodologies, and terminology and ensure adherence… more
- Aequor (Thousand Oaks, CA)
- …oversight skill set. Skills related to delivering training sessions. Experience with Veeva Quality Management Systems and Veeva Document Management Systems . ... Responsible for activities surrounding Deviations and CAPA processes; including maintaining metrics, scheduling training sessions, providing process guidance and serving as instructor on Deviations related training session. more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking CQV Specialist II as part of the Technical Operations team based in Raritan, NJ. ... management, issues, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans created for regulatory submissions. This… more
- Cipla (Fall River, MA)
- …Application Management Build technical understanding of MES applications, Serialization Software's, Quality Systems QC applications/software's and end to end ... Job Title IT Specialist Organization Name InvaGen Pharmaceuticals, Inc Location 927...and how to apply them to business scenarios. Understanding Quality Systems solutions, Quality software's,… more
- Cipla (Fall River, MA)
- Job Title : Quality Assurance Operation Specialist FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The QA operation specialist (MDI) monitors and ensures validation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Commercial, NNI IT and Telephony, Medical Information, Product Safety, Regulatory, Quality , Legal, Privacy and Finance. External relationships include Customer Care… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Biotech is seeking QC Specialist , Lab Services, II/III as part of the Quality team based in Raritan, NJ. Role OverviewThe QC Specialist , Lab Services is ... responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks...on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …batch related recordsPerform tasks in a manner consistent with the safety policies, quality systems and cGMP requirementsReview and approve SOPs, and other ... in the treatment of multiple myeloma.Legend Biotech is seeking QA Document Control Specialist I/II/III as part of the Quality team based in Raritan,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …from established internal contacts.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well as according to ... of multiple myeloma.Legend Biotech is seeking QA Batch Disposition Specialist II/III as part of the Quality ...in response to potential findings.Ability to utilize multiple electronic quality systems and SAP.Contribute to the improvement… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions (CAPA).Perform tasks in a manner consistent with the safety policies, quality systems and cGMPrequirements.Works in a collaborative team setting with ... treatment of multiple myeloma.Legend Biotech is seeking QC Investigations Specialist II as part of the Quality ...Investigations Specialist II as part of the Quality team based in Raritan, NJ. Role OverviewThe QC… more
- Merck & Co. (Rahway, NJ)
- …of the Client Audit Director (CAD) and the Auditor-in-Charge (AIC), the Senior Specialist will:Participate in the execution of financial, operational, SOX 404 and IT ... 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
- Merck & Co. (Durham, NC)
- …in a leading biopharmaceutical company? We are seeking a dedicated and organized Sr. Specialist to join our team. In this role, you will centrally receive and track ... Supplier Change Notification process. If you excel in data analysis and systems use, this opportunity is for you. Responsibilities Manage change notifications from… more
- ALPCO (Denver, CO)
- …knowledge of immunoassay principles, diagnostics, and instrumentation. Familiarity with quality management systems (ISO 13485). Strong organizational skills: ... how to apply ALPCO’s solutions in their workflows. The Field Applications Specialist will serve as a trusted advisor to clinical, academic, and pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …supplies. Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply and/or ... Acceptance Testing (UAT) for assigned studies. Utilization of key technological tools and systems for GCS planning such as SWMS, Veeva, MEDS, MyLearning, SAP and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …labels and documents prior to use on the manufacturing floor.Utilize multiple electronic quality systems , batch records and SAP.Work in a team based, ... multiple myeloma.Legend Biotech is seeking a QA Shop Floor Specialist II/III as part of the Quality ...as needed.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well… more
- Merck & Co. (Rahway, NJ)
- …Global Clinical Trial Operations (GCTO) Regional colleagues and Global - Development Quality (GDQ) to address clinical supply related topics. - Responsible and ... customer relationship management. - Technical Proficiency: familiarity with supply chain systems and software (eg SAP or Oracle) and demand planning principles… more
