- Aequor (Thousand Oaks, CA)
- …equivalent combination of education and/or experience. Typically 2 plus years of related quality assurance or manufacturing experience in a GMP pharmaceutical or ... meet deadlines. Basic statistical mathematical skills including the ability to trend data . Basic project management skills. Independently understand, follow and… more
- Aequor (MA)
- …other document types. Provides iShift support for GMID and BOM approval. Support of data analysis and metrics for Quality Council, KPls, and other reportable ... manufacturing documents for the timely initiation of GMP manufacturing activities. Provides Quality oversight and Quality guidance to resolve compliance issues… more
- Insmed Incorporated (San Diego, CA)
- …effectiveness of the Quality department.Assist in other quality assurance related activities as agreed with management .Job Requirements:Minimum BS degree ... Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Associate Director, Quality Assurance - Analytical,GMP has responsibility for the QA… more
- Eisai, Inc (Nutley, NJ)
- …and regional teams on information security and protection, as well as data privacy initiatives.This role involves substantial global management across Tokyo, ... technical and assurance principles relating to information security and global data protection laws or regulations, such as DPA, GDPR, HIPAA, China Cybersecurity… more
- Tris Pharma (Monmouth Junction, NJ)
- … Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ... risk management principles in the design (and resolution) of key quality management system elements to ensure complianceTracks and trends deviations and… more
- Merck & Co. (North Wales, PA)
- …deliverable quality and process compliance.Familiarity with statistics and clinical data management concepts. Preferred Experience and Skills: Strong working ... global programming standards and tools for the production of Study Data Tabulation Model (SDTM) datasets.Design and develop complex programming algorithms and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the support for management and update of technical registration documents- Quality Metrics: Collecting and analyzing data related to deviations, CAPA, Change ... diseases and immune disorders.Summary Accountable for support and manage Quality Management System (QMS) in accordance with...for GMP area. Responsible for the creation and review Quality Assurance Agreements with contract organization and… more
- Insmed Incorporated (San Diego, CA)
- …for stability and sample management (eg, JMP, Labware LIMS)Collaborate with Quality Assurance , Manufacturing and CMOs, Material Management , and other ... of areas of responsibility.Participate in daily and weekly operation meetings and Quality Management Reviews.Own and support stability and sample management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tech Unit Team culture. Service as a primary contact with Legal and Quality Assurance regarding records Retention and Training Coordination. Demonstration and ... targets and create variances report. Maintaining vendor contracts, contractor data , and critical database information.Responsibilities- Project Management - Plan… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …patient-specific, finished drug product batches by collaborating with all functions (including Quality Assurance , Quality Control, Operations, Vein to Vein, ... minimum 5 years of relevant work experience in Operations, Supply Chain, or Quality Assurance experience within a cGMP environment Facilitate cross functional… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to 20/30 (Snellen) or betterWorks in a collaborative team setting with quality counterparts that include Quality Assurance , Manufacturing Operations, ... that the candidate have experience working in an aseptic manufacturing facility, preferably in quality control, quality assurance , or cell therapy. A minimum… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …required. Advanced degree preferred.A minimum of 5 years of operations or quality Assurance experience within a cGMP environment in the biotech/biopharma ... cell and gene therapy manufacturing, including but not limited to deviations ( Quality Issues), investigations, CAPA management .Work cross functionally with SME's… more
- Merck & Co. (Rahway, NJ)
- …continue advancing medical innovation and improve lives.Our Company Corporate Audit and Assurance Services' (MCAAS) mission is to create confidence in a changing ... world.-We provide value-added independent and risk-based audit, assurance and advisory services.Position Responsibilities:The successful incumbents will need to… more
- Merck & Co. (Millsboro, DE)
- …collaborate with your colleagues from BTS-PD, BTS-Analytical, Operations, Engineering, Quality Control/ Assurance , Supply Chain, Planning, Regulatory Affairs, ... work in the manufacturing plants with a "Safety First, Quality Always" mindset striving for continuous improvement. We work...in the Bio Technology Solutions (BTS) department is on management of a team of scientists and/or engineers, Vaccine… more
- Merck & Co. (Rahway, NJ)
- …develop a breadth of experience including finance, accounting, analytics, risk management , and special project opportunities.Corporate Audit and Assurance ... Analytics preferred, but all business majors may be considered (including Management , Marketing, or Economics).-Academic curriculum focus on data analytics… more
- BioAgilytix (Boston, MA)
- … on initiatives and projects related to system implementation (eg, integrations, data integrity and risk management ).Perform periodic application review and ... operation, and maintenance of laboratory systems such as Laboratory Information Management Systems (LIMS), Chromatography Data Systems, microbiology laboratory… more
- Merck & Co. (North Wales, PA)
- …various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... phase-appropriate validation, early and late-stage transfers, analytical life cycle management , and release and stability testing. The successful candidate must… more
- Merck & Co. (North Wales, PA)
- …an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM standardsExperience ... to anticipate stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance. Strong… more
- Merck & Co. (Rahway, NJ)
- …various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance , Technical Operations, and CMC Regulatory Affairs, ... and FDA regulations.Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.-Knowledge of deviation management and change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has advanced skills in technology systems, content creation, word processing software and data management software, and business emailing software as well as ... years of professional experience within the pharmaceutical industry working within Quality Assurance is required.Must have a broad understanding of… more
