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Online Resumes with "Track wise"
Technical Writer, Philadelphia metro, NYC, Connecticut, New Jersey
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, Validation, Technical Writer, Microsoft Excell, Change Control, Microsoft Office, Microsoft Visio Professional, Microsoft Word, GMP
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
Production Manager - 20 Years of Experience - Near 32825
PROFILE A strategic results-driven Quality / Validation, Operations, Engineering, and Project Management Professional with more than 15 years of experience in world class Pharmaceuticals and Medical Device industries. Vast experience compliance of cGMPs and associated regulations, investigations and corrective actions (NC & CAPA), remediation's planning/budgeting and execution of commitments to FDA, equipment and facilities...
Tags for this Online Resume: Quality Assurance, Budgeting, Complaints, Compliance, Consulting, Corrective Actions, CVS, Distribution, Engineering, Management
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
Operations Director - 20 Years of Experience - Near 92887
Seasoned operations leader and culture expert with over 15 years of increasingly responsible management experience, most recently in the pharmaceutical industry. Expertise includes improving operational efficiency and creating an environment where top-notch employees are mentored and appreciated, thus reducing employee turnover. Strong CAPA experience and Lean Six Sigma Yellow Belt Certification. BA degree.
Tags for this Online Resume: Budgeting, Business Development, Management, Performance Management, Project Management, Pharmaceuticals, Manufacturing, Sales, Marketing, P&L, Mentoring, Performance Improvement, TrackWise, Publishing, Training, Technical Writing, Editing, Desktop Publishing, Team Building, Leadership, Strategic Planning, Auditing, Regulatory Compliance
Life Scientist - 15 Years of Experience - Near 19426
To secure a position as a Senior Quality System Consultant.
Tags for this Online Resume: Validation Specialist, Quality Specialist, SAP, Annual Product Review, Auditor, Investigation CAPA, TrackWise, Batch Release, Documentation, Product Development
Senior Supervisor Manufacturing
SUMMARY I have extensive pharmaceutical leadership experience in biotech and parenteral drug manufacturing environment. Diversified experience in sterile manufacturing including bulk manufacturing, aseptic filling, component sterilization, freeze drying, environmental monitoring, inspection and packaging. I have knowledge of governmental cGMP, OSHA, DEA regulation and procedures, experience with FDA, EU and other regulatory...
Tags for this Online Resume: Desktop Computer, Inventory, Leadership, Management, Manufacturing, Microsoft, Microsoft Office, Monitoring, Novell, Novell Netware, pharmaceutical, Aseptic Filling, Packaging, Bulk formulation, sap
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
Quality Assurance Engineer - QSR/ISO13485 - Validation
To work for a Medical Device company where my experience and skills in Quality Assurance and Validation can be put to good use. What I value most in my career: 1) Personal confidence that I can do the job/task. 2) Upper management confidence that I can do the job/task. 3) Satisfaction that the career/job I’m doing is worthwhile and benefits others. 4) People important in my life recognize value in what I do and that I ...
Ideal Companies: Roche, Johnson&Johnson, Genentech, Eli Lilly
Tags for this Online Resume: Quality Assurance, Medical Device, Validation, ISO 13485 Auditor, TrackWise, Validation - Process, Equipment, ISO 13485 Compliance Auditor, Risk Management, ISO, ISO 9001
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
QA Professional - Former FDA CDER 15 years experience, ASQ CQE, CQA, CQMgr-OE, Microbiologist,- DC
Former FDA CDER Compliance Officer with 15 years experience in Pharma QA seeks Leadership position in QA Regulatory Compliance, Investigations, Audits
Ideal Companies: Solvay, Sciele, Monsanto, ConAgra, Bayer, CR Bard, etc. Novartis, Shionogi, CIBA Vision, Alcon, Allergan, Coca Cola, Johnson and Johnson, Pfizer
Tags for this Online Resume: TrackWise, Investigations, CAPAs, APRs, Minitab, SPC, SAS-JMP/Discovery, SAP, QA, Compliance, Medical Device, Pharmaceuticals, Biotechnology