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Online Resumes with "Warning Letters"
Galen Neher - A different kind of rookie knows he will succeed if given the chance.
At this stage of my career, I am looking for a change in direction that will be both challenging and rewarding. An entry level pharma/medical device sales position is just the sort of thing that I am looking for.
Ideal Companies: Large, mid-sized , or small pharma or biotech or mdeical device company. Quality of the products is much more important than size of the company.
Tags for this Online Resume: highly experienced, flexable, dependable, excellent verbal and writing skills
Risk Air Traffic Controller
Risk Coordinator- Specializing in unemoloyment processing and training, first aid Workers compensation claims.
Ideal Companies: US Government, Starbucks, Microsoft, Sony, Disney, NBC, CBS, Fox
Tags for this Online Resume: Risk Management, Unemployment, Training
Goal focused Quality Leader in medical devices and pharmaceuticals
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
Instrument/ Metrology Technician - 15 years of Experience- Puerto Rico
CAREER TARGET: Instrument / Calibration Technician Well qualified to leverage extensive Pharmaceutical and Biomedical Industries knowledge, skills, and experience Metrology Lead and Instrument/ Calibration Technical with extensive experience in the Pharmaceutical and Medical Device Industry leading the Metrology Department. Motivated individual that accepts responsibility, is a fast learner, and has the ability to manag...
Principal PCB Designer
Looking for a mid/senior level as an individual contributor. A job that would allow growth into a managerial position that would reflect my previous experience in use of design tools as well as managing a multi-faceted team of professional.
Ideal Companies: Intel, Texas Instruments, lSI, Dell Computers
Tags for this Online Resume: Cadence Allegro 16.5 S032, Cadence Capture CIS 16.5, Mentor Graphics DX Designer (ePD 2005), View Logic, Microsoft Office Suite, Visio, BlueBeam
Sr. Exec with over 20 yrs in Medical Device, Biotech & Pharma
Sr. Exec. with over 20 years in medical device , biotech and the pharmaceutical industries. Specialize in Transformations and Compliance Improvement Program management. QSIT expert with experience in resolving FDA 483's, Warning Letters and Consent Decrees. Background includes Ops, R&D, QA and IT.
Quality and/or Safety Manager
I am a highly accomplished science professional who would like to use my 15 years of experience designing and implementing Quality Systems and Environmental Health & Safety Programs to manager a companies facilities and/or product quality, regulatory and safety compliance. I can leverage my extensive knowledge of quality and safety systems to manage all levels of both product and process implementation including, documentat...
Ideal Companies: Ideal companies I would like to work for will be in the science and technology sector within a 30 mile radius of zip code 06405. Examples of large companies include Covidein (North Haven), Phillips (Meridan), Perkin Elmer (Shelton), Unilever (Trumbull), BMS (Wallingford). Smaller companies are concentrated in Wallingford, Meridan, Milford and New Haven. Yale, Southern Connecticut State, and Quinnipac Universities are also potential opportunities.
Tags for this Online Resume: Quality Assurance, FDA Compliance, EHS Management, Strategic Planning, Research and Development, Operations Management, Project Management, Cross-Functional Leadership, Technical Support/Writing, Customer Satisfaction, Continuous Process Improvement, Team Building/Training and Mentoring
Quality Engineer - 20 Years of Experience - Near 30022
I have been involved with numerious FDA regulated manufacturers in both the pharmaceutical as well as the medical device industry sectors in supporting them in meeting their FDA warning letter violations. These directives encompass 21 CFR Part 210 / 211 and 21 CFR Part 803, 806, 809 & 820 compliance statues. I pride myself in assisting team members in not only understand what the FDA is asking of them, but to enhance the ...
Tags for this Online Resume: quality assurance, regulatory compliance, engineering
Compliance Manager - 18 Years of Experience - Near 92128
A Quality Assurance and Regulatory Compliance leader with over 17 years of hands-on experience in Class I, II and Class III cardiovascular medical devices (implantable defibrillators), disposable products, patient monitoring devices, mobile medical devices/apps and combination drug/device products. Held various positions with increasing authority and responsibilities in management and functions which have led to comprehen...
Tags for this Online Resume: Quality Assurance / Operations , CAPA Management , Process Engineering , Change Control , Internal / External Audits , Lean /Six Sigma, Quality System management, Complaint management
SR. PHARMACEUTICAL QUALITY SYSTEMS & VALIDATION PROFESSIONAL
Seeking Pharmaceutical QA Position - - Full Time or Consulting Position SR. PHARMACEUTICAL QUALITY SYSTEMS AND VALIDATION PROFESSIONAL with a broad knowledge of regulatory compliance and quality control and assurance expertise in cGMP manufacturing, operations, regulatory, supply chain management, and validation as applied to aseptic parental pharmaceutical products, tablets, APIs, and medical devices. My experience in...
Ideal Companies: Pharmaceutical or Medical Device Companies, (Abbott; Abbvie; Hospira, Johnson & Johnson)
Tags for this Online Resume: North Carolina, South Carolina, Florida, Texas, Missouri, Chicago, Atlanta, Associate Director of Quality Assurance, Quality Assurance Manager, Sr. Compliance QA Manager, Associate Director of Validation, Validation Director, CAPA Management, Supplier QA Manager, Director of Supplier Assurance, CMO QA Manager, Pharmaceutical QA Manager, Medical Device QA Manager, Corporate QA Auditor, CAPA Manager, API Manufacturer, Sterile Fill Pharmaceutical Manufacturer, Medical Device Manufacturer, Sr. Quality Engineer, Oklahoma, Illinois, Milwaukee WI, Validation Manager, Internal QA Auditor
Clinical Research
Tags for this Online Resume: Pricing, Pharmaceutical, Oncology, Licensing, Consulting, Research, Urology, Market Access, Patient Access, Outcomes Research, Health Economics, Neuroscience, Boston, Cambridge, Pharmaceutical Administration, Device, Biotechnology, Health Technology Assessment, Marketing, Policy, clinical trials, clinical research
Clinical Quality Assurance
SUMMARY OF QUALIFICAITONS * Global and domestic cGxP operation, quality and packaging experience in medical/precision and diagnostic devices, pharmaceuticals and biomedical industries * Managed Chemistry and Manufacturing Controls: including API sourcing, vender/raw material qualification, formulation, product/process development, scale-up, clinical supplies, technology transfer and validation * Wrote and compiled CMC porti...
Tags for this Online Resume: Cancer, Consumer Products, Engineering, OTC, Process Engineering, Product Development, Risk Analysis, Commercial Production, Team Lead, API
