- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in pharmaceutical or biotechnology in clinical trial operations or clinical quality assurance . required Experience Qualifications4 or More Years ... lessons learned. This role will also work with R&D Quality Assurance (R&D QA) and the respective...and quality management principles. requiredExpert knowledge in Clinical Operations Phase 1 to 4 Trial… more
- Catalent (Philadelphia, PA)
- …in Philadelphia, PA is hiring a QA Supervisor. The QA Supervisor will p rovide Quality Assurance support for the Quality Inspectors on the production floor, ... as the Quality partner to support the Supply Chain and Operations department. Act as site subject matter expert for "Good Manufacturing Practices" and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality ... Summary This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …functions (eg clinical research & development, clinical science, clinical quality assurance , project management) Preferred requiredStrong leadership, ... areas centered around rare diseases and immune disorders. Summary The Director, Global Clinical Operations (GCO) Clinical Trial Operational Risk & Oversight… more
- Catalent (Philadelphia, PA)
- …other related scientific discipline or equivalent experience. 15 + years of Scientific or Quality Assurance in clinical trials packaging, in addition of ... Control, and Customer relations.The Role: Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance , Regulatory and… more
- Aequor (Thousand Oaks, CA)
- … Team by collaborating with diverse functional areas including Supply Chain, Manufacturing, Quality Control, Regulatory, Quality Assurance , Quality ... (PQ) organization as a subject matter expert of clinical and commercial product stability studies and GMP data...Doctorate degree OR Master's degree & 3 years of Quality , Operations , Scientific, or Manufacturing experience, OR… more
- Merck & Co. (North Wales, PA)
- …project management skillsDemonstrated success in the assurance of deliverable quality and process complianceFamiliarity with statistical and clinical data ... and providing tools and templates to support delivery focusing on traceability, quality assurance , data conformance and data fitness. The position is… more
- Merck & Co. (North Wales, PA)
- …to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong ... This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more… 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 - ... statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. -Accountability predominantly includes the development and… more
- Merck & Co. (North Wales, PA)
- …Experience/Skills We are Looking for: Minimum:-Bachelor's Degree in Regulatory Affairs, Quality Assurance , Clinical Affairs, Pharmacovigilance, Biology, ... RDH partners with functional leaders and teams within Digital Clinical Measures (DCM), Global Clinical Operations team (GCTO) and Business Development (BD)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(eg clinical research & development, clinical science, clinical quality assurance , project management) preferredStrong leadership, collaboration, ... around rare diseases and immune disorders.Summary The Associate Director, Global Clinical Operations (GCO) Procedural Ownership and Life Cycle Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of manufacturing operations and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supporting complaint and recall programs, . This position interacts with Quality Assurance (QA) sub-functional and cross-functional teams, as well as ... a timely investigation and that protective solutions identified to avoid significant quality or patient. Execute all recall operations activities and process… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate hasexperience working in an aseptic manufacturing facility, preferably in quality assurance ,manufacturing compliance, clinical quality , or ... Quality Control, Information Technology, Maintenance, Manufacturing personnel, Technical Operations personnel, Human Resources, Site Leadership Team members, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance , Medical Affairs, Translational Research, Research, ... the US, EU, Japan, and other global sites. These business functions include: Clinical Operations , Clinical Development, Biostatistics and Data Management,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance , manufacturing compliance, clinical quality , ... and complaint product supply. Key Responsibilities Support compliance activities for site Quality Operations in accordance with Legend standards, procedures and… more
- Volunteers of America Mid-States (Louisville, KY)
- …programs within programs) as needed. 19. Assist with special projects such as Quality Assurance and to assist with ensuring compliance with COA standards ... POSITION TITLE: Clinical Therapist - Women's (Freedom House) LOCATION: Louisville,...on a consistent basis. Will also assist with daily operations /crisis intervention as needed. Will have some on-call and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance , or manufacturing compliance Knowledge of cGMP regulations ... is seeking a CQV Specialist (Contract Position) as part of the Technical Operations team based in Raritan, NJ. Role Overview This position will be responsible… more
- Eisai, Inc (Nutley, NJ)
- …security and data privacy standards. Your responsibilities span security operations , risk assessment, investigations, and compliance issue resolution for the ... Business Relationships:Promotes awareness of standards related to security, regulatory, clinical , commercial, and manufacturing processes to establish a culture of… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …position that will be responsible for administrative and instructional duties. The EMS Quality Assurance Coordinator is responsible under the direction of the ... EMS and EMS Medical Director for ensuring the operational quality and continuous clinical improvement of EMS...chart reviews of all high-priority cases.Conduct audits of EMS operations to assess compliance with state and national standards… more
