- Eisai, Inc (Nutley, NJ)
- …to standards.Oversee regional security vendors.Prioritize risk-based reduction efforts. Manager investigations .General Compliance Activities:Maintain an inventory ... privacy standards. Your responsibilities span security operations, risk assessment, investigations , and compliance issue resolution for the Americas business. You… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based in Raritan, NJ. ... Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction and leadership for the … more
- Catalent (St. Petersburg, FL)
- QA Product Manager Position SummaryThe QA Product Manager is responsible for providing Leadership and Quality Assurance Management support within at Catalent's ... Quality Systems, Finished Product Batch Release, and Change Control.The QA Product Manager provides customer service, with the highest integrity, focused on quality… more
- BioAgilytix (Durham, NC)
- …life-saving therapeutics to the patients who need them.We're seeking an experienced Manager of Employee Relations to join us at our Durham location, which ... ability to be on-site 3-4 days per week in our Durham, NC location. The Manager of Employee Relations will play a pivotal part in fostering a positive work… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …investigation and operation. Supports the receipt, logging, and assignment of complaint investigations for commercial and IMP drug products to ensure a timely ... when necessary.Deviation Investigation Program: Manages and participates in the deviation investigations for commercial and IMP as a result of distribution… more
- Aequor (Seattle, WA)
- …Function as the Quality liaison with contract test labs during QC investigations Represent the Cell therapy Analytical Sciences and Technology department on ... cross-functional drug product teams. Qualifications, skills and education requirements BS/MS in relevant scientific discipline and 2&plus years (or equivalent combination) experience within a regulated (GMP) biopharmaceutical, cellular therapy, or gene therapy… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking a Warehouse Operations Manager as part of the Technical Operations team based in Raritan. Role Overview ... The Warehouse Operations Manager will work within Technical Operations and be responsible...the treatment and on time closure of deviations, Quality investigations and CAPA's related to operational activities. Ensure good… more
- Novo Nordisk Inc. (Durham, NC)
- …developing & executing tactical & strategic plans. Relationships Senior Manager , Facilities, Utilities, Systems, Equipment (FUSE). Essential Functions Develop, coach ... to better/best practices & projects Ensure completion of high-level projects & investigations Follow all safety and environmental requirements in the performance of… more
- Insmed Incorporated (San Diego, CA)
- …QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks ... with respect to troubleshooting instrumentation, out of specification/atypical results investigations , analytical methods and reports, review and approval of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...for the manufacturing process, equipment, and associated deviations and investigations within a cell therapy manufacturing plant to support… more
- Aequor (Thousand Oaks, CA)
- …reports) Approve planned incidents) Represent QA on NPI team) Lead investigations ) Lead plant audits, participate in site audits) Approve change-over completion) ... May perform work of QA Specialist EDUCATION/LICENSES Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience. Previous managerial experience directly managing people and/or… more
- Merck & Co. (Rahway, NJ)
- …database tracking.- Facilitate and/or participate in deviations reporting, investigations and any related corrective action/preventive action (CAPA).- Facilitate ... & Environmental Policies and Procedures.Technical writing validation documents, protocols, investigations , change requests, standard operating procedures, etc.-Maintenance & Engineering… more
- Aequor (Thousand Oaks, CA)
- Manager is requesting candidates college GPA in the supplier notes of the resume if the candidate is willing to disclose. 8-5pm - Fully Onsite Experience: Open to a ... process controls, analytical methods, specifications, reference standards, importation testing, investigations , change control, regulatory submissions and inspections. The PQL… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Raritan functions, particularly the Quality Control (QC), Quality, and Deviation Investigations Teams, to identify and address bottlenecks. Coordination with Global ... (KPIs) and ensure timely reporting to the Site General Manager . Problem Solving: Address and resolve any issues that...across 2 companies. Internal: QC Team, Quality Team, Deviation Investigations Team, Raritan SLT. External: Global MSAT and ASAT… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …assistance is available for this role. Relationships Reports to: QC Manager Number of subordinates with direct/indirect referral: 5-10 Essential Functions Oversee ... trending files, and provides routine summaries of trending to support investigations Assists with other routine laboratory investigations including analyst… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …and relocation assistance package is available. Relationships Reports to: Manager , Automation Engineering Number of subordinates with direct/indirect referral: none, ... areas including the following activities: Support for resolution of deviations, investigations , and other quality issues Assists with the design, procurement,… more
- Novo Nordisk Inc. (Durham, NC)
- …Process Professional and as a mentor/coach for junior team members. Relationships Manager . The role is responsible for collaborating with stakeholders related to ... team members. Essential Functions Responsible for providing in depth deviation investigations and root cause analysis Drive continuous improvements via Lean tools… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …performance and other areas. You will report to the Manager , Microbiology.Job ResponsibilitiesProvide general oversight, plan, organize, direct, and evaluate ... for department and respond to audit observations.Lead technical reviews, investigations , and process improvement projects.Identify, and oversee changes within… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …quality systems, and cGMP requirements. Support manufacturing investigations , create/revise operational procedures, including manufacturing work instructions, ... forms, and support and manage change controls. Work closely with Operations Manager to help oversee the development of production personnel, provide input on… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …This role will support our QC teams under the direction of the QC Manager . Relationships Reports to: Quality Control Manager Number of subordinates with ... with the ability to manage Change Controls Support deviation and CAPA investigations and corrective actions Support of Health Authority inspections Support area… more
