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FDA resumes in New Castle, DE

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Project Manager Product Development

Kennett Square, PA, 19348
... SPECIAL EXPERTISE Run reliable and sensitive analytical instrumentation: Infrared Fourier Transform Spectroscopy Strong experience with SOPs, Good Laboratory Practices (GLP), International Organization for Standardization (ISO), FDA, and safety ... - 2017 Mar 25

PTCB, Certified in Aseptic Techniques,Compounding,Handling of Hazards

Wilmington, DE
... My pharmacy career is stabilized in closed door, filling technician, long- term care arena with eight years’ experience, focused abilities to detail where SOP, GMP and FDA regulations apply, Nonsterile compounding. Certified in Aseptic Techniques & ... - 2017 Mar 19

Director/Manager of Quality Assurance

Newark, DE
... Liaison for regulatory agencies (FDA, STATE/CLIA, AABB, EU and customers). Regulatory submissions to the FDA along with the annual reports and BPDR’s, in addition maintained establishment licenses. Conducted GMP training. Championed process ... - 2017 Feb 22

Pharmacist II Clinical

Glen Mills, PA
... prescription and drug therapy issues to prescribers Counsel patients based on clinical judgment Submit adverse events to FDA and manufactures Review prescriptions for accuracy and clinical rational Verify accuracy of completed prescriptions ... - 2017 Jan 14

Customer Service Medical

Middletown, DE
... Deep expertise in FDA CFR 21 800 through 862 and post market surveillance. Excellent results with 10+ years of experience with clinical trials and data submissions; Critical review of study protocols and hands-on experience on selections and ... - 2017 Jan 10

Clinical Research Associate

Ridley Park, PA
... Ensure compliance of ongoing trials to protocols, FDA and GCP. Talents include in-depth knowledge of ICH guidelines, SAE reporting and GCP auditing. Well versed in liaising with Health care professionals. Profound Know how of handling, filing and ... - 2016 Oct 20

CIO, CTO, VP of IT, Sr. Director of Global Systems

Pitman, NJ, 08071
... Oversaw the designed, negotiation and implementation of two missions critical Vision Inspection Systems at our FDA regulated facility to address Type II through Type V drugs for our pharmaceutical customers. Implemented Job Costing at QPSI. This ... - 2016 Aug 08

Associate Director Regulatory Operations

Glenolden, PA, 19036
... Managed a yearly $500K capital budget and built an electronic submissions group from the ground up exploring novel ways and various platforms for BLA and NDA submissions before the advent of FDA electronic submission. Researched and purchased ... - 2016 Jul 24

Medical Device, Clinical Trials, Lab Operations, R&D

Middletown, DE
... FDA submission; clinical trials, FDA CFR 21 800 through 862; GMP, GLP; CLIA lab operations; QA/QS and QC QUALIFICATIONS Business leadership and executive experience in large companies, Fortune 500 equivalent Business development and effective R&D ... - 2016 Jun 24

Project Manager Management

Wilmington, DE
... implementations oImplementations centered on extensive Computer System Validation and stringent quality requirements in an FDA regulated environment throughout the Software Development Lifecycle oFully integrated SOPs with validated testing results ... - 2016 Jun 09
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