- Aequor (Thousand Oaks, CA)
- …Verifications, Supplier Event Notifications and Investigations (SICAR /EN), and Change Control quality records. This Specialist Manufacturing will act as the ... control. They will be familiar with Veeva or TrackWise systems and come from a biotech (preferred) or medical...Supply representative across functional teams and drive closure of quality records in a timely manner. The Specialist… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …actions.Perform tasks in a manner consistent with the safety policies, quality systems , and cGMP requirements.Drive continuous improvementOther duties may ... immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking a QA Validation Specialist III as part of the Quality team based in Raritan, NJ.Role… more
- Aequor (Framingham, MA)
- Shift: 1st Work Schedule: Mon-Fri 800-430The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring ... cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems , and strong knowledge of global pharmaceutical… more
- Merck & Co. (Durham, NC)
- …manufacturer? If so, then this is the opportunity for you! The Senior Specialist , Engineer is a member of the Engineering team providing technical support within ... and maintenance of HVAC, and -clean utility equipment and systems (WFI, Clean Steam, HVAC, and CDA), utility equipment...problem-solving skills and a hands-on approach to problem solving. Quality & Safety Compliance: Must be fully aware of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for new members.Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.Review change controls, SOPs, and other ... multiple myeloma.Legend Biotech is seeking a QA Change Control Specialist II as part of the Quality ...GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Operational experience with electronic quality systems .Familiarity with core Quality … more
- Merck & Co. (Rahway, NJ)
- …with the communications roadmap. Partner with development teams to ensure high- quality delivery using Agile methodologies. Act as product owner through delivery, ... communications comply with relevant regulations and standards, partnering with compliance and quality teams as needed. Risk & Issue Management Capture and manage… 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 III as part of the Quality ...as needed.Consistently perform tasks in adherence with safety policies, quality systems , and cGMP requirements, as well… more
- ALPCO (CA)
- …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
- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …format.Perform tasks on time in a manner consistent with safety policies, quality systems , and cGMP requirements.Build strong partnerships with Manufacturing, ... treatment of multiple myeloma.Legend Biotech is seeking Operations Support Specialist as part of the Technical Operations team based...Warehouse, Engineering, and Quality , and work as part of a cross-functional team… 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
- Cipla (Fall River, MA)
- Job Title : Quality Assurance (QMS) Production Lead FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General: 8:30AM - 5:00PM ... based on business needs) Reports To : QA Manager Purpose: The purpose of the Quality Assurance Production Lead (QMS) is to monitor and ensure product quality is… 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
- 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
- Aequor (Bend, OR)
- …knowledge of GMP regulations Support implementation and continuous improvement of Quality Systems Control record management including receipt, reconciliation, ... scanning and verification, record check-out/check-in and maintain scanned record back-ups Controlled document issuance and tracking Support audit activities Controlled numbering issuance and tracking Perform other duties as assigned Work experience:… 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
- Credence (Wright-Patterson AFB, OH)
- …achieve greater success. Credence has an immediate need for a Security Management Specialist to support Headquarters Air Force Material Command (HQ AFMC) A/2 at ... security vulnerabilities Implementation of preventive measures Oversee and implement the quality management system Physical Security - Inspect, analyze, and evaluate… more
- Cipla (Reid, WI)
- Job Title : Pkg. Documentation Specialist II FLSA Classification : Professional, Exempt Work Location : Fall River, MA Work Hours: General Shift: 8:30AM - 5:00PM ... is searching for experienced candidates for the position of Documentation Specialist . The Documentation Specialist is responsible for the creation… more
