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Online Resumes with "FDA"



Professional Manufacturing Manager

Effectively lead people and teams to solve day – to – day operational problems, ensure product quality and maintain profitability. Decisive, results oriented and adaptable individual, with a demonstrated capability to achieve immediate and long-term organizational goals. Exhibits strong leadership in critical areas of production control, quality, and inventory control, product and process improvement and personnel management.

Ideal Companies: Mid-size manufacturing company which can use my skill sets and experience to help achieve profitability.

Strong leadership, Motatvated and Team player. Ensures job is completed correctly

I am looking for a challange to showcase my work history.

Ideal Companies: Health Industry, Operations

Tags for this Online Resume: Patient safety, Key Performance indicators, Business Plan, Honor, Courage, Commitment

Quality Engineer

Tags for this Online Resume: Auditor, 13485, 9001, Quality Manager, FDA, Corrective Actions and Preventive Actions

Strategic HR Professional

I love a challenge and have a proven track record for translating corporate and cultural objectives into positive, effective HR practices. Regardless of the project, industry, or HR issue, my focus is on building respect for the HR profession and creating an environment where employees thrive.

Ideal Companies: Mid-size to larger companies.

Tags for this Online Resume: HR Business Partner, HR Strategy

Process Technician- 10 years experience- biotechnology and pharmaceuticals.

Biotech or pharmaceutical manufacturing or research position in which I can apply my combined technical skills and ten years experience working in a cGMP and FDA regulated environment.

Tags for this Online Resume: SAP, LIMS, Microsoft Word, Batch record and SOP authorship, Palltronics Flowstar filter tester, MicrofiltrA

Regulatory Affairs Specialist

I Seek a fulltime Regulatory Affairs professional position that will utilize the achievements, skills, strategic thinking and leadership abilities that enable me to aid the company in timely submission packets; Wereby we consistently exceed earnings potentials and achieve company goals in any of today's global economic markets.

Tags for this Online Resume: Regulatory Affairs Professional, FDA 510(k), PMA, IDE, ICH, CE Markings, EU MDD, CMDCAS

Senior Regulatory Writer (17 years experience)

I am seeking to end my present consulting status and return to an in-house position where continuity of projects is more realized. I have over 15 years experience writing regulatory medical documents that comprise CFR21 356h NDA/BLAs and eCTDs deliverables to the FDA/EU/Canadian regulatory authorities. I have written approximately 85 CSRs and can confidently say that ~40 of these were NCEs, early phase I/II and some pha...

Tags for this Online Resume: Regulatory Medical Writer Manager level

Niki Haag

Focused, hard working, ambitious, confident, determined, intelligent, innovative

Ideal Companies: Progressive, Bonne Bell, Edward Jones, National City, Key, Sherwin Williams

Production / QA Supervisor

Obtain a challenging Production supervisor/ QA Management position in manufacturing to enhance current productivity, assist in exceeding company goals, and meet the customer's needs.

Tags for this Online Resume: QA, Scheduling, management, Production, project, SOP/GMP/FDA

cGMP Quality Control and Assurance, Molecular Biologist, 15 years of experience

Personable, motivated and astute, business-minded life scientist with extensive experience in Quality Control labs using advanced molecular biology techniques in PCR, RT-PCR, qPCR; Excellent communicator with broad experience in CLIA-certified and FDA-regulated environments.

Tags for this Online Resume: qPCR, cGMP, Trackwise, IQOQPQ, validation, Quality

Pharmaceutical sales

10701 Club Chase Fishers, Indiana 46038 Telephone: 317 696 9549 TLJR40@aol.com PROFILE Diligent results oriented sales professional with a consistent record of accomplishment in Global Sales Organizations. Expert at utilizing consultative sales techniques used to identify and capitalize on business growth opportunities. Experienced in launching new drugs across multiple market segments and Disease States in Centr...

Tags for this Online Resume: sales, customer service

Production Manager

Tags for this Online Resume: FDA, SOP, EPA, OSHA, DEA, cGMP, National Safety Council First Aid - Heart Saver CPR, IMS Safety, Hazwoper Awareness 29CFR 1910.120, Haz-Mat 49CFR, Docket HM-126F-HM181, Respirator Training Instructor, Care Maintenance Inspection of Punches/Dies, ISOTrain Group / Change Control Depart, Powered Industrial Trucks/Operator Certification, Removal of hazardous/non-hazardous waste disposal, ISOTraining, IMS Training, Hazardous/non-hazardous waste disposal, Hazwoper Awareness , Haz-Mat , Care/Maintenance/Inspection of Punches/Dies, Film Coating Technology, Papavarine Seeds preparation