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Online Resumes with "master file"



Featured Profile

Research

To obtain a challenging position within the Pharmaceutical industry or medical devices industry that will allow me to use my experience to play a key role in Clinical Research studies and projects, and/or product development with medical devices.

Tags for this Online Resume: Clinical Pathology, laboratory method development, IQ, OQ, PQ, instrumentation, validation of medical devices, Regulatory, GLP, GCP, IRB, TMF, Project Manager, Documentation Specialist, Scientist, Archives

Featured Profile

Clinical Research - 6 Years of Experience - Near 92649

Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.

Ideal Companies: inventiv, johnson & johnson, covance, covidien, peregrine

Tags for this Online Resume: Irvine, CCRP, regulatory affairs, clinical project manager, EDC, budgets , timelines, contracts and budgets

Featured Profile

Support Specialist - 9 Years of Experience - Near 48167

Working in an office environment with analytics and strategic planning key to the position. Working for a company that values associates and continued education in all positions.

Tags for this Online Resume: Microsoft Office Suite, HQPMM, SMM, BRData, SQL Queries, Data Entry, Data Analytics, Creative Solutions

Clinical Research - 2 Years of Experience - Near 98033

Two years’ experience with clinical responsibilities for medical device companies with Class II devices – including an in-vitro molecular diagnostics device to detect infectious disease and a dermatological radiofrequency device that ablates nerves to reduce forehead wrinkles. Qualifications include leading a recruitment effort to secure 65 patients in 3 months across 5 sites, experience conducting and monitoring GCP phase ...

Tags for this Online Resume: monitoring, GCP, clinical research , Seattle, diagnostics, medical device , vendor , in-vitro

Director of Quality - 20 Years of Experience - Near 91325

To utilize my Education, professional experience and expertise on pharmaceuticals, Nutraceuticals, and Personal care products to improve productivity and reduce production cost by managing rework, waste control and proper schedule to finish the assign job on time. Extensive practical experience in formulation, Development, Optimization, Scale-up, Validation and tech-transfer activities for the following: *Generic pharmaceu...

Tags for this Online Resume: Director Research and development and production, cGMP, GMP, SOP, CMC, QBD, Quality by Design, scale up, validation, Monitoring, DMF, CTD, drug master file, Injection, parenterals, Lyphilization, Tablets, Capsule, Cosmetics, cream, lotion, gels, softgel, powder for drinks, Liposoms, ethosoms, Sustain Release tablet, control release tablet, Granulation, compression, Coating, Formulation, production, Medical device, Drug loading, drug delivery, Autoclave, ETO gas sterilization, steam sterilization, Heat sterilization, Depyrogen sterilization, Large volume parenteral, small volume parenteral, ophalmic ointment,eye drops,

Medical Office Manager - 1 Years of Experience - Near 02120

Seeking a position to utilize my skills and abilities in the corporate sector that offers professional growth which is being resourceful, innovative and flexible. Knowledge of ICH guidelines and safety reporting requirements, good manufacturing practices (GMP), good laboratory practice (GLP) and good clinical practices (GCP). Understanding of FDA regulations and knowledge of IND, NDA, BLA, Drug Master File (DMF), 510(k) and...

Tags for this Online Resume: Boston, GLP, GCP, FDA Regulations, Medical Device

QA - 20 Years of Experience - Near 39426

Pharmacopeia upgrade monograph tests for Dimethyl Sulfoxide. * Monitor and update USOSHA and foreign country SDS sheets and product label / placard required for a wide array of products. * Played an integral role in securing the EU Certificate of Suitability (CEP) for Procipient Dimethyl Sulfoxide in 2014. and Health Canada Drug Master Files (DMF) for Dimethyl Sulfoxide to ensure compliance and enhance clarity. Maintained r...

Ideal Companies: 1 month -

Tags for this Online Resume: Audit, Pharmaceutical, Quality Assurance, Test, DMS, Dms (Data Mgmt Tool), QA/QC, ISO, Management, Instrumentation

Featured Profile

Facilities Manager

SUMMARY Proficient in Commercial Property Management & Finance in Fortune 500 Company responsible for major buildings in the Banking & Financial Services Industry. Extensive experience in building operations. With continuous growth through mergers & acquisitions, this dynamic culture provided the back drop to become a skilled communicator & to develop excellent customer service skills. A proficient facilitator adapting quic...

Tags for this Online Resume: Facilities Management, Management, Customer Service, Planning, Forecasting, Training, Jacksonville, Fl, Team Building, Contracts, Budgeting, Vendor Management, Communicator, Leader, Reporting, Negotiator, Accounting, Space Planning, Construction, Project Management

Health Technologist - 9 Years of Experience - Near 44092

Professional Summary Professional Summary Over twenty-five years' experience in healthcare financial management with a broad range of responsibilities. Work background has included extensive training for Patient Access and Revenue Management, master file and profile analysis, system build and maintenance, current and future state analysis, coordination and performance of system testing including high volume, unit, and integ...

Tags for this Online Resume: Management, Revenue Management, Financials, Health Care Industry, Billing, Business Analysis, Business Analyst, Agile Methodologies, Agile methodology, Financial

Clinical Research - 20 Years of Experience - Near 12553

SUMMARY Self-motivated, dedicated and hardworking professional with greater than 30 years of experience in Clinical Operations (Clinical Associate, Trial Master File, Grants & Payments) and Clinical Development & Medical Affairs within the pharmaceutical industry. Major strengths include excellent communication and organizational skills. CORE STRENGTHS Knowledge in Clinical Trials and Drug Development for Clinical Developme...

Tags for this Online Resume: Clinical Trial Associate, Immunology, Clinical Operations, Medical, Medical Affairs, Oncology, C Programming Language, Cardiovascular, Database, Hepatitis, clinical, phase, oncology, trial, protocol, gcp, pharmaceutical, ich, TMF, Clinical Payments, sap

Mental Health Therapist - 14 Years of Experience - Near 33157

Summary of 10/2010 to 06/2017, Yassin Homes, Inc. St. Paul, MN Qualifications Home Community Base (IRTS) Program Facility Manager and Mental Health Counselor/Therapist * Responsible for the day to day operation of a community based adult home facility (HCBS/IRTS). Maintain resident's master file, personal files, financial records and other documentation alike. Providing individual and group therapy to an adult population. S...

Tags for this Online Resume: Assessments, Compliance, Documentation, English Language, Evaluate, Progress, Reviews, Services, Mental Helath Substance Abuse Counselor

Certified Clinical Research Coordinator - 13 Years of Experience - Near 34202

Seasoned Certified Clinical Research Coordinator with 13 years' experience as a CRC, including experience in marketing, advertising, and regulatory document completion and submission. Completed my duties with great attention to detail, compassion, professionalism, confidentiality, and care. Seeking a position in healthcare/clinical research/pharmaceutical industry that will allow me to continue to exercise these skills and ...

Tags for this Online Resume: Clinical Research, Research, Good Clinical Practices, Protocol, Advertising, Documentation, Marketing Management, NPI, Training, Accounts Payable, clinical, trial, phase, gcp, protocol, pharmaceutical, GCP, IRB, CRF, ich, AE, SAE, SUSAR, Inclusion and Exclusion Criteria, ECG, Biological, PK, PG, Substudy, ICF, EDC, Rater, concomitant medications, IP, IP accountability, regulatory documents, master file