- Aequor (Chattanooga, TN)
- …turnover documention from execution and as-built drawings. Based on level, demonstrated project controls skills such as estimating, scheduling and cost ... Leadership skills. Proficient with Microsoft Office products (Excel, Word, PowerPoint, etc.).. Years of Experience: 1 - 3 Years Heavy Project Management Exp more
- BioAgilytix (Durham, NC)
- … project plans, manage resources, track budgets, and handle change control processes to meet project objectives efficiently.Problem-solving and adaptability: ... of 5 years of IT experience in varied roles.At least 3 years of IT Project Management experience managing complex projects across business systems and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …to-or leading-Quality process improvement initiatives. Job ResponsibilitiesManages the Documentation Control Unit to ensure the following:Document Change Controls ... Change Control Program.Review all documentation associated with EFP Change Controls and ensure compliance to Good Manufacturing Practice (GMP), internal Good… more
- Aequor (Swiftwater, MN)
- …activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for the site, including the update of CMC files. The incumbent ... Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2. 3 and 3 ) to support Marketing Authorizations...CMC Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise… more
- Merck & Co. (Rahway, NJ)
- …including finance, accounting, analytics, risk management, and special project opportunities.Corporate Audit and Assurance Services (MCAAS) Finance Leadership ... of the company's strategy; this includes a deeper knowledge of internal controls , business compliance, and risk management. Individuals will be based in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …required- 3 + Concur Travel & Entertainment software experience preferred- 3 + years Accounts Payable Project experience preferred TravelInternational travel ... systems are operating well as designed. Ensures compliance with internal controls and accounting policies. Optimizes Financial Disbursement technology through system… more
- Aequor (Thousand Oaks, CA)
- …role is an organized and detail-oriented professional with experience in document control and project coordination, preferably within regulated environments like ... Any time zone. 1 year potential for extension to 3 years. typical schedule follows standard business, some flexibility...- CDOCs). Track and provide regular updates to Smartsheet project plan and to key Points of Contact. Requirements… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …individual will support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support regulatory ... a cGMP environment in the biotech/biopharma industry with a minimum of 3 years supervisory experience. Cell/Gene Therapy experience preferred.An ability to build… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …associated regulatory areas including Product Labeling, Chemistry, Manufacturing and Controls , Policy and Intelligence Work with knowledgeable mentors and develop ... participatein certain department activities and initiatives related to the project . Education/Experience: Currently enrolled full-time and have completed at least… more
- Aequor (Bothell, WA)
- …years of Experience Planning and leading small and medium-sized projects preferred. 3 &plus years of Experience Supporting multiple projects, ability to multi-task ... site and global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT, validation, and… more
- Aequor (Thousand Oaks, CA)
- …knowledge of healthcare regulations, business requirements and legal compliance. 3 . Maintain contract documentation and ensure compliance with contractual terms ... payments and adherence to payment terms. 11. Ensure compliance with internal controls , policies, and regulations. 12. Develop and enforce policies and procedures… more
- Christus Health (Irving, TX)
- …application knowledge to meet operational and organizational needs. Project implementation responsibilities include collaborating with customers contributing to ... solutions and business processes to meet operational and technical Collaborates across project borders with other teams. Thinks outside the box and proposes… more
- Merck & Co. (Upper Gwynedd, PA)
- …business partners (ie co-development of products with other pharmaceutical companies); and 3 ) Ensuring that essential elements of the quality management system are ... commitments.Assesses and provides input to strengthen company programs/strategies (eg Quality Control Visit (QCV), Headquarters Quality Control Protocol (HQ QCP)… more
- Merck & Co. (Durham, NC)
- …support groups.This is a night shift position, 12-hour (6:00pm - 6:00am) rotation (2-2- 3 ).-The successful candidate for this position will work an hourly 2, 2, ... 3 shift schedule (12 hours shift, 2 days on,...recommending spare parts, selecting lubrication processes and assisting process project engineers.Assists with execution of automation, validation and additional… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Health Authority inspections Acquires technical expertise on the function and control of applicable department equipment and techniques related to job function, ... new processes from Product Support, Engineering, EH&S, and OE as directed Serves as project member or project leader on improvement programs as needed Supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …1) Head of OEDC and KEE Chair, 2) Scientific Committee Chair, and 3 ) Infrastructure Committee Chair. This position is critical in transforming Daiichi Sankyo (DS) ... 1) Head of OEDC and KEE Chair, 2) Scientific Committee Chair, and 3 ) Infrastructure Committee Chair, the Program Lead will ensure a smooth operating environment.… more
- Merck & Co. (Durham, NC)
- …technology capabilities/solutions with quality policies and objectives. Ensure the initial project tailoring is appropriate for the complexity and risk to ... in a validated status (eg, problem and incident management, change control , periodic review, investigations, backup/restore, System Use and Administrative SOPs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization ... works closely with statistical programmers in statistical analyses execution, quality control , and data derivation; collaborates closely with data manager to ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Therapy Area and for relevant in-line and new product commercialization assets ( 3 years prior to launch). They will lead the development and implementation ... negotiations and ensures optimal label for pipeline assets Responsible for project management and coordination including overall ownership of launch activities and… more
- Tris Pharma (Monmouth Junction, NJ)
- …method validation activities, including interim method validation, to meet project timelines. Supports laboratory investigations and performance of non-routine ... Master's Degree in Chemistry or related scientific field, with at least three ( 3 +) years of experience in analytical development and/or method validation in the… more
