- SMBC (Charlotte, NC)
- …CyberDW to understand their structure, relationships, dependencies to quantify and document the data quality rules, controls and lineage around the key ... This critical role will be responsible for leading the Data Governance & Data Quality ...accountability, traceability, and reporting across all test cycles. + Lead the QA Testing efforts that will design and… more
- Cipla (Fall River, MA)
- …associates to ensure they are qualified prior to beginning their daily functions. Acts as quality lead for all shop floor questions/concerns. Acts as back up for ... Job Title : Quality Assurance (QMS) Production Lead FLSA...Review of engineering records such as temperature and humidity data calibrations, preventive maintenance records, pest control … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …appropriate sub-teams particularly validation, data analytics (including CPV), quality compliance (including change control and investigations), and ... therapy product in the Multiple Myeloma space including validation, data analytics and commercial support. The Quality ...The Quality Compliance scope includes working on Quality related sub-teams such as change control … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …investigations, CAPAs, change controls and complaints.Perform analysis on quality indicating data and identifying trends.Contribute to maintain investigation ... treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead I as part of the Quality ...Investigations Lead I as part of the Quality team based in Raritan, NJ. Role OverviewThe QA… more
- Twist BioScience (South San Francisco, CA)
- …as ISO 13485, ISO 14971, and the FDA's Quality System Regulation (QSR). Lead internal CAPAs related to Supplier Controls . Lead high visibility complaints ... prevent recurrence of non-conformities.Provide technical support to the R&D team on quality matters, including design control , process validation, and change … more
- Merck & Co. (Durham, NC)
- …12.5 hour (6:30 PM-6:30AM) rotation (2-2-3). - The Vaccine Manufacturing Facility Lead Technician is an excellent opportunity for highly motivated individuals with ... expertise working in aseptic production and manufacturing operations. -The Lead Technician is a manager developmental role and will serve on the Operations… more
- Merck & Co. (Rahway, NJ)
- …or related industryExperience in one or more functional areas such as quality control , quality assurance, analytical laboratories, manufacturing, production ... Manufacturing Practices (GMP), Immunochemistry, Interpersonal Relationships, Manufacturing Processes, Manufacturing Quality Control , Microbiology, Molecular Microbiology, Physiology, Process… more
- Repligen (Waltham, MA)
- …controls by design."Maintain ITGC narratives, process flows, and risk/ control matrices.Identify and drive process improvements, automation opportunities, and ... an experienced IT Manager, SOX & ITGC Compliance to lead the design, implementation, and ongoing effectiveness of internal...standardization across ITGC and SOX processes.Utilize data analytics to enhance testing quality , reduce… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking QA Investigations Lead III as part of the Quality team based in Raritan, NJ. ... Role OverviewThe QA Investigations Lead is responsible for providing quality oversight over the production of a personalized cell therapy to support both… more
- Merck & Co. (Rahway, NJ)
- …benefits realization Lead cross-functional delivery programs (software, controls , integrations, data /analytics, automation vendors), ensuring disciplined ... of contact for manufacturing leadership, engineering, commercial teams, supply chain, quality , IT, and external partners/vendors. Lead stakeholder engagement… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Merck & Co. (Rahway, NJ)
- …acceptable related experience.Required Experience and Skills:- Strong knowledge of cGMP, Quality Systems, Safety, Environmental, data integrity, and validation ... Job DescriptionThe Senior Automation Specialist provides end-to-end automation and quality engineering support for the Rahway, NJ FLEx (Formulation, Laboratory &… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …Experience.Required Skills: Accounting, Accounting, Adaptability, Asset Accounting, Audit Internal Controls , Contract Audits, Data Analysis, Financial Advising, ... both domestic and abroad to maintain a strong internal control environment at our company.On occasion, the incumbent will...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …within budget, per direction, and are internally consistent with group deliverable quality Systems and Data Management Responsible for gross-to-net forecast ... and evolving business needs Continuously reviews and evaluates the quality of data and new data...Compliance and Finance Responsible for ensuring that all rebate controls meet all audit and internal control … more
- Cipla (Fall River, MA)
- …of all the equipment and associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup for shop floor QA ... such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing… more
- Cipla (Fall River, MA)
- …as required. Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and follow detailed documentation procedures to ... (May vary based on business needs) Reports To : Quality Assurance Manager Salary Range : $21 - $26...Review of engineering records such as temperature and humidity data calibration and PM records, Pest control … more
- Repligen (Waltham, MA)
- …to business strategy, while overseeing internal teams, MSPs, and vendors to ensure high- quality , secure, and reliable services.You will lead and develop a ... leadership for incident and problem resolution.Oversee network, cloud, server, data center, storage, telecommunications, industrial control systems, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. Controls and assures the quality of the material content of any ... of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and...maintenance of signal tool and support tasks of change control , training material update, and end user support or… more
- Cipla (Reid, WI)
- …Provides data to support management evaluation of performance trends. Owns quality records (change control , CAPA's, deviations) and delivers to established ... the validation programs and strategies to customers and regulatory auditors. Performs weekly quality reviews of Master Control database by assuring new documents… more
