- Merck & Co. (Durham, NC)
- …hands-on approach to problem solving, and be self-motivated to identify and lead process improvement projects.The Quality Assurance Specialist provides support ... Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Risk… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. The Clinical Quality Assurance Professional (QAP) position is responsible for design, delivery and execution of the ... global Clinical Quality Assurance (CQA) strategy including audit and inspection management, issue...plan.Champion CQA's mission of 'Quality as enabler of business'; lead global initiatives for continuous improvement.Trend and leverage internal… more
- Insmed Incorporated (NJ)
- …of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from ... 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Category Sourcing Lead as part of the Global Operations team based in Raritan, NJ. Role ... innovation, pioneering work and evolving best practices.The Global Sourcing Category Lead is responsible for leading global sourcing activities for direct materials… more
- Insmed Incorporated (San Diego, CA)
- …a key team member. \tProvide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state ... security requirements. \tEnsure compliance and operational efficiency of validated systems through participating in release management, change control, periodic… more
- BioAgilytix (Durham, NC)
- …build the rules, processes, and cloud pipelines that keep lab and business information accurate, secure, and easy to find. That means hands-on work designing Azure ... quality, access control, and compliance protocols.Define standards, build quality assurance processes, and monitor data integrity to meet regulatory requirements,… more
- Merck & Co. (Millsboro, DE)
- …as needed. - Assists in the management and execution of critical quality systems such as change control, document management, Deviation management, etc. - Performs ... as they apply to the biologics field or a related area - Quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas- - Understanding of… 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 ... vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The...associated controls during the batch run. Act as quality lead for all shop floor questions / concerns. Backup… more
- Capital One (Chicago, IL)
- … security (application security, network security, cyber security, data protection), information systems risk management, information systems ... Cyber or Technology Operations, such as Cloud provider certifications, Certified Information Systems Security Professional (CISSP), or Certified Information… more
- Cipla (Central Islip, NY)
- …- 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background and ... position include but are not limited to the following: Scope: The Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor… more
- Nevada System of Higher Education (Las Vegas, NV)
- …Certified Internal Auditor (CIA), Certified Public Accountant (CPA), or Certified Information Systems Auditor (CISA) required. Candidates currently pursuing ... of Regents policies. Audit methodologies for financial, operational, compliance, and information systems reviews. Techniques for risk assessment, process… more
- Cipla (Fall River, MA)
- …procedure as per Current Good Manufacturing Practices (cGMP) guidelines by Quality Assurance (QA). Check and monitor for cleanliness, maintenance, upkeep of the ... the site internally and externally. Install and troubleshoot facility electrical systems . Coordinate in Technology Transfer / Product Transfer with other… more
- Capital One (Newport News, VA)
- …years of experience in internal or external auditing, accounting, financial analysis, information systems , compliance, risk management or a combination At least ... Qualifications: Bachelor's Degree in Accounting, Finance, Economics, Business Administration, or Information Systems 2+ years of experience leading audits and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Customer Engagement Programs, and other CMR Functional areas. This job will lead a team of Patient Safety training and vendor training oversight managers and ... GxP Documentation Management Develop and implement comprehensive documentation management systems and processes for all GxP documentation, ensuring adherence to… more
- Merck & Co. (Rahway, NJ)
- …Contract Audits, Data Analysis, Financial Advising, Financial Analysis, General Accounting, Information Technology (IT) Systems , Information Technology ... Job DescriptionOur company's Audit and Assurance Services primary purpose is to provide value-added...our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management… more
- Merck & Co. (Rahway, NJ)
- …products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems . The director will lead a team of engineers and technical ... needs of manufacturing are considered as part of the design.- Provide information and drive early alignment and readiness reviews with manufacturing partners to… more
- Insmed Incorporated (NJ)
- … specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other Clinical/Manufacturing systems .Project lead experience preferred.Strong experience in Clinical Study ... a key team member. Provide guidance and support to ensure Insmed computerized systems are deployed following lifecycle management and remain in a validated state (eg… more
- BOEING (Hazelwood, MO)
- …units (LRUs), and RF/C4ISR interfaces. Ensure cyber security and information assurance compliance across network designs (segmentation, encryption, ... Lead requirements decomposition, traceability, and verification activities with systems engineering and software/hardware teams. Specify and select network… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and site-specific procedures.The position requires in-depth knowledge of ERP systems in a Manufacturing/Supply Chain environment, strong analytical and advanced ... requirements and disruption to supply.Maintain system planning parameters (eg lot size, lead -time and safety stock levels) within the site ERP.Assist with the… more
- Novo Nordisk Inc. (Boulder, CO)
- …perform formulation studies in a laboratory setting as needed. This position will lead a team of Drug Product Managers and manage their own projects. Relationships ... This position reports to the Executive Director, Manufacturing. Essential Functions Lead , manage, and advise all aspects of drug product manufacturing operations at… more
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