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Online Resumes with "cGMP "
Director- Global Operations- 20+ years of experience- Manufacturing of Biologicals-Technical Transfer-develop people-GMP compliance-Regulatory submissions-
Expertise in managing Supply chain for a 1.5 Billion dollar Medical Device Reagents business. Technical, Quality and Regulatory background to manage the business under FDA compliance.
Ideal Companies: Johnson and Johnson, Celgene, Sanofi, Novo Nordisk, Bristol-myers Squibb,
Tags for this Online Resume: Manufacturing Biologics, Protein Purification, Microbial Fermentation, CGMP, FDA Compliance, Protein Characterization, Quality Control, Regulatory Submissions, Quality Audits, Six Sigma Black belt
Sr. Mechanical Maintenance Lead - 12 years - Amgen - Facilities & Engineering
Experience as Senior Maintenance/Facilities Maintenance Technician with ability to apply practical as well as theoretical knowledge in non-routine situations; Subject Matter Expert; strong mechanical aptitude. Adept in leading and executing preliminary, corrective, and preventive maintenance programs; following established guidelines and Standard Operating Procedures (SOPs); building successful and productive teams. In-d...
Tags for this Online Resume: cGMP, SOP, BioPharm, Mechanical, Maintenance , Safety
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
Business Analyst
Tags for this Online Resume: Strong lab skills, with ability to perform detail-oriented work with a high degree of accuracy., Basic hands on knowledge of flow cytometry, including instrument platforms and software and assay applications., Basic engineering principles, troubleshooting, statistics and study design, including effective analytical and problem solving skills. , Familiar with general cGMP / cGLP procedures with a strong focus on quality. , Manufacturing, R&D, Quality and CAPA , Proficient with MS Word, MS Excel, MS PowerPoint, and MS SharePoint
sales representative, foreign trained medical doctor, US citizen
I am a physician with over 14 years experience in clinical medicine, staffing and administration. I also hold a BA in chemistry with over 14 years experience in bench chemistry, research and development, CGMP, OSHA regulations and FDA filing protocol of ANDAs (Abbreviated New Drug applications). I cannot wait to be employed in sales by a pharmaceutical company where I will work with the team to enhance the company's goals a...
Quality Manager - 20 Years of Experience - in food and pharmaceuticals
Looking for a Quality Control/Assurance/Manager/System position in the food/pharmaceutical/medical device/nutrient/suppliant industry that needs an experienced Quality Manager to help ensure safe, wholesome, fit for use, quality products are produced. An organization that is on a quality journey striving to achieve and/or maintain certifications in ISO, GSFI, SQF, etc. my knowledge, skills, and training will be a perfect f...
Tags for this Online Resume: ISO , cGMP, Quality Control, Quality manager, QMS, Internal Audit, CAPA, HACCP
Production Laborers - 10 Years of Experience - Near 27520
CAREER OBJECTIVE To secure a position within a major pharmaceutical company so that I may apply my ten years of production experience and training to the manufacture of high quality pharmaceutical products. To initiate a career with that company that is rewarding and continually evolving through my ability to consistently execute and improve proven processes. To keep a focus towards improving product manufacture as well as...
Tags for this Online Resume: Pharmaceutical, CGMP, SAP, documentation, Microsoft word, Citrix, Lean Manufacturing, Chromotography
Materials Scientist - 20 Years of Experience - Near 45011
Jonathan K. Mentzer 6964 Beagle Dr. Fairfield Twp, Ohio 45011 jmentzer6964@yahoo.com Home # 513-863-2974 The responsibilities at NEASE CO. LLC included resolving any quality issues that may occur. All instrument preventative maintenance and repairs are now the responsibility of the Quality Assurance and Quality Control (QA/QC) Supervisor. Writing, reviewing and training of procedures within the department to maintain C...
Biochemist - 20 Years of Experience - Near 91935
Looking for a position in application or technical support, technical writing, protein chemistry, or immunology. !5 years of experience in vaccine research and development and protein purification up to gram scale and some under cGMP.
Tags for this Online Resume: flow cytometry, technical support, protein chemistry, vaccine development, San Diego, scale-up, immunology, technical writing
Experienced Quality Leader
Executive level professional that really enjoys the challenge of hands on problem solving. I enjoy building powerful teams across departments that focus on bringing out the best in each other and moving towards making things better and working smarter. I have years of experience in batch document review, investigating deviations, handling of regulatory interfaces such as inspections, leading and managing quality technical a...
Tags for this Online Resume: north Carolina, Continuous Improvement, Leader, Quality, Systems Builder, Emotional Intelligence
Quality Assurance - 11 yrs experience - Phila., PA 19145
• Works to build a rapport giving guidance and support to operational staff to develop an environment of teamwork and effective communication with a result of achieving organizational goals. Responsible for goals pertaining to cGMP, GLP, CFR's, Association of Blood Bank (AABB) regulations and assure compliance with 22 organization Quality Systems.
Tags for this Online Resume: Auditing, Inspections, guidance, support, CAPA, writing polcies and proceudres
Technician - 20 Years of Experience - Near 08097
experience of 22 years in a FDA, CGMP regulated laboratory state of the art lab. I performed infectious disease testing and D.N.A.testing
Tags for this Online Resume: Philadelphia, cgmp enviornment, focused, reliable, independent worker, lab technician , research
