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Online Resumes with "TrackWise"



Microbiologist - 20 Years of Experience - Near 07753

Summary I am a Scientist with twenty nine years of professional experience in the pharmaceutical, medical device, clinical and biotech industries. I have written SOPs, CAPA, audit reports, validation master plans, protocols, new product submissions and various other technical documents. I am very familiar with QSR, 21CFR211 and ISO standards: 13485, 14644 part 1 and part 2. I have used the five "whys" and fishbone methods f...

Tags for this Online Resume: Data Entry, Documentation, Root Cause Analysis, Technical Writing, Packaging, ISO, Pharmaceutical, Statistical Analysis, Audit, Management, pharmaceutical, sap

Clinical Quality Assurance - 15 Years of Experience - Near 03811

Tags for this Online Resume: Complaints, Documentation, Pharmaceutical Industry, Quality, Quality Assurance, Quality Control, Risk Analysis, Test, Compliance, Kaizen, trackwise, batch record review, CAPA, deviations, audit, VEEVA

Quality Engineer

ACCOMPLISHMENTS & ACHIEVEMENTS * Researched and budgeted for a vast array of new soldering tips and equipment, microscopes, and specialized lens accessories, and a CMM in order to significantly improve inspection results. Automated SPC measurement systems that resulted in real-time data collection cost savings of $480,000. * Champion of lean six sigma and continuous improvement techniques within Kaizen culture. Became subje...

Tags for this Online Resume: Audit, Legacy, ISO, Management, Procurement, Quality, Quality Assurance, Quality Management, Test, Compliance

Chemist - 20 Years of Experience - Near 27856

Tags for this Online Resume: Pharmaceutical, chemist, Quality, Project, Supervisor, Audit, Manufacturing, Chemistry, Microsoft Word, 5S, sap, Trackwise

Quality Manager - 12 Years of Experience - Near 19120

I am equipped with 25+ years of experience in Documentation Design/Development and Technical Writing. I am currently exploring gainful opportunity prospects in Pharma and Bio Research. * Analytical and detail-oriented Technical Writer, with vast experience in technical documentation development across various industries. Strong background in writing with superb written communication skills. Expert knowledge in document life...

Tags for this Online Resume: Documentation, Manufacturing, Integrate, Oracle, Graphical User Interface, Intranet, Microsoft Visio, Microsoft Visio Professional, Microsoft Word, Statistical Analysis, Technical Writer, Documentum, Sharepoint, Trackwise

Quality Coordinator

SUMMARY: * Analytical Chemist with over ten (10) years of R&D, Quality Control/Quality Assurance and performance experience in diverse areas of chemistry including pharmaceuticals and food products. * Thorough knowledge of theory, use, simple repair and maintenance of typical analytical instrumentation including HPLC, GC, FTIR, UV/VIS AND Dissolution. * Excellent ability to identify compounds based on spectrochemical and /o...

Tags for this Online Resume: Documentation, Control Data, High Performance Liquid Chromatography (HPLC), Pharmaceutical, Chemistry, Instrumentation, Quality, Quality Assurance, Complaints, Management

Quality Manager - 12 Years of Experience

Professional Summary Self-motivated, energetic and effective leader with 13+ years of experience (8Years of leadership/managerial role) in quality assurance in pharmaceuticals, biologics, Complex injectables, Oncology and combination products. Proven to successfully design and implement quality systems and drive positive change in fast paced environments. Decisive leader who will apply initiative and innovation to establish...

Tags for this Online Resume: Management, Oncology, Manufacturing, Quality Assurance, Test, Quality, Quality Management, Documentation, Audit, Filing

Production Manager - 15 Years of Experience - Near 32803

Professional with a strong operational experience within the pharmaceutical industry. Vast knowledge of manufacturing operations including manufacturing packaging inventory systems engineering maintenance systems auditing process improvements (Lean) technology transfer for new products validations qualifications and facilities modifications/construction project management. Certified Project Management Professional. Trainer ...

Tags for this Online Resume: Manufacturing, Management, Project Management, Project Manager, Audit, Complaints, Customer Accounts, Pharmaceutical, Microsoft, Microsoft Project, "project management", manufacturing

Department Manager

PROFESSIONAL SUMMARY Dynamic Environmental, Health, Safety and Quality professional with twenty years of experience in the pharmaceutical industry (oral solid dosage and active pharmaceutical ingredient). Strong knowledge in Project Management, Manufacturing, Operations, Equipment Qualification and Process Validation. Expertise in regulated environments: cGMP compliance, OSHA, EPA, PSM and FDA. Teamwork oriented and Leaders...

Tags for this Online Resume: Project Management, Compliance, FDA, cGMP, Process Engineer, Sr. Safety Engineer, PSM, Training, OSHA, CQA

Microbiologist

PROFESSIONAL SUMMARY * Experienced Compliance Reviewer, Quality Control and QA Specialist. * Manufacturing professional with 17 years in GMP controlled manufacturing suites and lab environment seeks a position offering professional growth and stability. * Thrive in challenging environments and am always seeking new ways to improve workplace efficiency. * Skilled in validation of laboratory instruments including those with c...

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

Featured Profile

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