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Online Resumes with "Process Analytics"
Biochemist - 18 Years of Experience - Near 21224
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with de...
Tags for this Online Resume: Reviews, Chemistry, CMOS, Compliance, Documentation, Drafting, Product Development, Security, Systems Development, High Performance Liquid Chromatography (HPLC), pharmaceutical
Mail Clerk - 7 Years of Experience - Near 10460
SUMMARY OF PROFESSIONAL DUTIES AND COMPETENCIES: Project and Quality Management * Ascertained quality and quantity of necessary resources and created budget proposals to ensure sufficient funding * Conducted internal audits of expenditures and use of resources to ensure efficient use of resources per company guidelines * Collected and analyze production samples to evaluate quality. * Analyzed quality control test results an...
Tags for this Online Resume: Delivery Driver, Accounting, Accounting Principles, Budgeting, Control Systems, Evaluate, Financial, Management, Project Management, Quality
Manager - 20 Years of Experience - Near 19481-0366
SUMMARY Described as a "5 tool player" by colleagues and clients, focused on winning new business through a variety of innovative strategies and increasing the share of wallet in existing accounts. Proven record of accomplishment for developing "Win Strategies" which produce results. Focused on Large Enterprise/Global Corporations and Federal, State, and Local Governments. Effective communication with Executive Suite and Se...
Tags for this Online Resume: Business Intelligence, Customer Relationship Management, Enterprise Resource Planning, Help Desk, Information Technology, Infrastructure, Integrate, Management, Planning, Product Lifecycle Management, c++, it jobs, javascript, sql, software
Business Analyst - 17 Years of Experience - Near 30346
Summary of Qualifications: * Successful history of data monetization taking it from raw data, to action and insight * Successful history of applying Design Thinking methodology to setup Data Governance COE, and Data Analytics COE * Successful history of leading enterprise data management 100-Day plan, and multi-generational plan * Successful history of leading development of Analytics paradigm, framework, and capabilities *...
Tags for this Online Resume: Security, Data Warehouse, Framework, Information Security, Data Management, Integrate, Management, SOA, API, Application Program Interface
Clinical Pharmacovigilance/Drug Safety - 20 Years of Experience - Near 95117
CAREER SUMMARY * Senior, seasoned pharmaceutical R&D professional with strong administrative, strategic & scientific planning, and coordination/execution skills, gained through 27 years of industrial experience in leading CMC technical development function (Pharmaceutics & Analytical), and leading global development & regulatory filings for NMEs (small molecule and biologics / mAb), and 505 (b) (2) products strong expertise...
Tags for this Online Resume: CMC, Product Development, Regulatory Affairs, Good Manufacturing Practices, Management, Project Management, Technical Lead, DP, Product Development, Supply Chain, Technical Operations
Project Manager - 20 Years of Experience - Near 08854
Professional Summary: Senior management and technology executive having over two decades of expertise in application and Data architecture and driving business objectives through advanced technologies. A highly accomplished Information Technology Professional backed by a proven track record of managing complex large scale integration projects and exceeding expectations. Extensive qualifications in all aspects of project lif...
Tags for this Online Resume: Documentation, BASIC Programming Language, Business Requirements, Stored Procedures, Structured Query Language, Technical Documentation, Visual Basic, Crystal Reports, Infrastructure, Banking Industry
Information Technology Manager - 14 Years of Experience - Near 10610
Summary I work with Business and IT Managers to bring projects to completion on scope, on time, on budget and with a higher level of adoption. I have a proven track record of using my IT project management and business process analytical skills to help reengineer processes, solve problems and drive innovation. I leverage my skills to help make technology projects return the value expected and the tools needed.
Ideal Companies: SUNY, CUNY, Non-profit
Tags for this Online Resume: Email, Help Desk, Assessments, Business Requirements, CIO, Application Development, Consulting, IBM, Lotus, Lotus Notes
Clinical Research Protocol Manager - 12 Years of Experience
Accomplished clinical research professional with progressive leadership experiences in clinical research practice, operations, and administration. Expertise in research strategy and process analytics, policy and procedures development, education, regulations and compliance, staff development, quality assurance and budget/financial management. Proven success in acquiring, evaluating, and managing multi-million dollar researc...
Tags for this Online Resume: Policies and Procedures, Protocol, Cancer, Audit, Clinical Research, Email, Infrastructure, Logistics, Oncology, clinical, phase iv, phase iii, phase ii, phase i, research, clinical trials, regulatory, compliance
General
Tags for this Online Resume: Assessments, Failure Analysis, Risk Assessment, SAP, Troubleshooting, Reliability, Good Manufacturing Practices, ISO, ISO 9001, Packaging
Local Government
Tags for this Online Resume: Quality, Quality Assurance, Quality Control, Control Data, D.O.T., Diversity, Engineering, Green Belt, Inventory, ISO
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
Chemist
Tags for this Online Resume: Pharmaceutical, Documentation, High Performance Liquid Chromatography (HPLC), Analytical Chemistry, Chemistry, Collection, Automation, Good Laboratory Practices, Instrumentation, Research
