CV, Curriculum Vitae and Online Resumes Search

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Online Resumes with "Batch records"

Quality Assurance Director - 4 Years of Experience - Near 08736

Accomplishments: * Led a group of 6 employees in a 24-person firm * Led a group of employees and consultants to file Icotinib IND to FDA for NSCLC * Directly handled post - IND interactions/questions with FDA * Lined up Accenture to handle eCTD publishing and submissions * Led a group to assemble and file Briefing Packages to UK, Canada, Australia and Singapore Regulatory Authorities set up and presented face-to-face meetin...

Tags for this Online Resume: Regulatory Affairs, Advertising, Business Plan, Filing, Assessments, Business Development, Chemistry, Consulting, Due Diligence, Integrate

Quality Coordinator - 15 Years of Experience - Near 33311

Qualifications 12/2005 - 09/2016 Watson Labs/Actavis/Allergan/Teva Davie, Sunrise and Weston, FL Senior Controlled Substances Coordinator / Site DEA Compliance Specialist Compiled data, accurately complete and submit quarterly ARCOS and Year End Reports by established due dates. Continuously monitor the receipt of Controlled Substances and List 1 Chemical materials purchased to ensure the Quota is not exceeded. Continuously...

Tags for this Online Resume: Audit, Compliance, Distribution, Documentation, Inventory, Manufacturing, Packaging, Controlled Substances, Policies and Procedures, Licensing

Not Listed - 20 Years of Experience - Near 07936

SUMMARY I have a Quality Assurance background (various areas of QA) with experience managing and overseeing QA processes in a Pharmaceutical and Medical Device regulated environment. Produce statistical documentation and communicate with senior-level managers regarding Quality Assurance/Training issues. Provide supervision and training to QA group members. Sustain quality and compliance levels. I am skilled in the following...

Tags for this Online Resume: Manufacturing, Test, Management, Audit, Validation, Database, Documentation, Microsoft Office, Quality, Quality Assurance, Investigations, Microbiologist

Marketing - Near 94401

Summary of Qualifications Seeking a position in Medical Affairs/Medical Writing/Regulatory Affairs/Marketing/Publications: * Pharmaceutical, Medical Device, Biotech and High Tech industry management experience and training * Expertise in translating complex technical, scientific and medical information into internal and global customer communications strong client communication skills Experienced with literature reviews, se...

Tags for this Online Resume: Advertising, Management, Project Management, Statistical Analysis, Telemarketing, Billing, Budgeting, Certificate Authority, CMM (Capability Maturity Model), Coding

Quality Manager - 14 Years of Experience - Near 00969

Summary of Qualification Electrical Engineer with broad experience in the Electronic, Electro Mechanic and Pharmaceutical Industries. Green Belt and ASQ-CQE Certified, Black Belt Trained. Strong knowledge on CFR, Aseptic Pharmaceutical Manufacturing Process and cGMP. Managed major document types as Annual Product Quality reports (APQRs), Master Batch Records (MBRs), Standard Operational Procedure (SOPs), Stability Studies a...

Tags for this Online Resume: Quality and Compliance, Audit, Budgeting, GMP, REgulatory, Data Management, Documentation, Fabrication, KPI metrics, Leadership, Management, Change Control

Biologist - 15 +Years of Experience - Near 33759

PROFESSIONAL PROFILE Solid experience in QA Regulatory Compliance world class companies. Interested in a challenging position with focus in QA Systems and Manufacturing operations fields. Broad knowledge in cGMP, ISO, EPA, DOT, FDA, and ANSI ASQC regulations. Working knowledge in sampling, inspection, and disposition processes, SPC, Change Controls, NC/CAPA, Validations, and Calibration systems. Highly organized, enjoy cha...

Tags for this Online Resume: Compliance, Documentation, Packaging, SPC, Test, Management, Quality, Quality Assurance, Quality Management, Assessments, pharmaceutical, sap, protocol, SOP, Validation, NC, CAPA, Change Control, Regulatory, Audit, GAP Assessments, Calibration, Raw Material, Incoming Inspection, Batch REcord Review, Classified Clean Rooms, Investigation Reports, Disposition, REserve Samples Program

Chemist - 2 Years of Experience - Near 27513

SUMMARY * * Goal-oriented with strong analytical, problem solving, and writing abilities. Experienced in a number of chemical quantification and characterization techniques including FTIR, fluorescence spectroscopy, TGA, HPLC, UV-vis, and GC-MS systems as well as Quality Assurance skills such as data review, batch record review, and the drafting of cGMP documentation including SOPs and Master Batch Records.

Tags for this Online Resume: High Performance Liquid Chromatography (HPLC), Documentation, Manufacturing, Pharmaceutical, Quality Assurance

Project Manager - 20 Years of Experience - Near 30655

HIGHLIGHTS OF QUALIFICATIONS * Providing Key Project Management (PMP) as well as hands on experience in the Acquisitions and Mergers of business technology and business practices into new business platforms. This would be the integrating old business legacy systems with new technology or integration into new owner systems and software. Mergers with Airline, Banking and Automotive companies. * Senior management consultant wi...

Tags for this Online Resume: Security, Cellular, Software, Software Development, Strategic Initiatives, ACD, Vignette, Adobe, Automatic Call Distribution, e-Commerce, it jobs, agile, software, sql, Senior Program / Project Manager, M&A Consultant

Quality Coordinator - 20 Years of Experience - Near 18353

Areas of Expertise & Technical Skills * Regulation Compliance * Agile (Scrum Master) * Internal/External Audits * Batch Record Reviews * CAPA / Risk Management * QA System Management & Implementations * Project Life Cycle * Technical Writing * Process Improvements * Six Sigma (Green Belt) * Document Controls * Software Implementation * CFR 210/211/820/803/58/11 * Team Training & Development

Tags for this Online Resume: Audit, Business Contingency Planning, Compliance, Documentation, Good Manufacturing Practices, Manufacturing, MDR, Packaging

Quality Coordinator - 3 Years of Experience - Near 27613

SUMMARY OF QUALIFICATIONS Results oriented professional with 10+ years experience in diverse industries and in multi-functional manufacturing environments with attention to quality control and safety. Demonstrated skills in: Inventory Operations / Technician Leadership Quality Inspections / Approved Procedures Equipment Operations / Maintenance SOP / cGMP / OJT Compliance Workstation Fundamentals Regulatory Compliance / Sta...

Tags for this Online Resume: Compliance, Manufacturing, Documentation, Housekeeping, Inventory, Logistics, Packaging, Vitals, Administrative Assistant, Grinder

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

Production Supervisor - 13 Years of Experience - Near 48217

Areas of Expertise * Process Improvements * Overhead Reduction * Operations Leadership * Staff Training/Management * Safety/Regulatory Compliance * Technical Support * Program Oversight * Schedule/SOP Development * CAPA/NCRM Investigations Career Highlights/Achievements * Implemented process improvements for mixing area cleaning pumps, resulting in more than $400 cost savings on each of 10+ mixes done each week. * Developed...

Tags for this Online Resume: Packaging, Manufacturing, Protocol, Training, Scheduling, Audit, Integrate, Management, Process Improvements, Recruiting, manufacturing, reliability, production