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West Warwick, RI, 02893
... Dartmouth Major: Bachelor of Science, Bioengineering, May 2017 Related Course Work Biomeasurment and control (instrumentation), FDA regulation & Classification, Medical ultrasound, Biomedical Devices, Biostatistics, Biomaterials, Biomechanics, ...
- 2017 Sep 21
Norwich, CT
... Document Management: Paradigm P3 FDA-compliant system. Implement laptop and device encryption and SHOPHOS threat management. Network Administration – Implemented cloud-based multi-level backups, home directories, data security, group policy and ...
- 2017 May 14
Killingly, CT
... PROFESSIONAL EXPERIENCE Tower Laboratories, Ltd January 2008 to April 2016 Centerbrook, Ct Position: Compliance Manager Duties and Responsibilities: Ensure corporate compliance to FDA cGMP regulations in Drug, Medical Device and Dietary Supplement ...
- 2016 Jul 10
Westerly, RI
... 2013 – Dec 2014 QUALITY CONTROL Smith and Nephew - Mansfield, MA Medical Surgical Equipment http://www.smith-nephew.com/ •Responsible for quality inspection of FDA regulated surgical equipment •Worked at the end of the assembly line in a clean room ...
- 2016 Apr 20
Groton, CT
... Knowledge of 21 CFR and FDA regulations and incorporated cGMP practices for writing validation master plan for IQ,PQ, and OQ. of mAb facility. PROFESSIONAL EXPERIENCE: Precision Castings Corp: Rework Engineer, Nov 2014-present Groton, Connecticut ...
- 2016 Feb 08
New London, CT
... for effectiveness) ● Create/review laboratory SOPs, protocols, validation reports ● Participated in internal and external (FDA) laboratory audits ● Communicated pertinent information across laboratory teams to meet challenging deadlines ● Prepared ...
- 2015 Sep 14
Westerly, RI
... August 2008-Present Analyze raw materials, proto-samples, pre/post production samples and incoming manufactured products via XRF analysis for non-compliance with cGMP, FDA, CPSIA AND CAL PROP 65. o Created/revise SOP’s for sampling collection, XRF ...
- 2014 May 06
Warwick, RI
... • Supervise contractors in the field to ensure Amgen Standard Operating Procedures, Amgen Manufacturing Procedures, OHSA and GMP/FDA guideline measures are met. • Guide field contractors in scheduling, manpower and material purchases are within ...
- 2014 Feb 06
Warwick, RI
... Knowledge of cGMP's, OSHA, FDA regulations and Lean and Six Sigma concepts. . Technically proficient. Microsoft Office (Excel, Power Point, Word). Working experience with POMS, Calibration Manager, MVDA, Minitab, QDMS, SAP and LIMS. . Good oral, ...
- 2013 Nov 09
North Kingstown, RI
... Clinical Data Standards implementation in compliance with FDA. Conditions: CDISC (Clinical Data Interchange Standard Consortium), CDASH (Clinical Data Acquisition Standards Harmonization). AVERION 09/2008-02/2009 Southborough, MA Clinical Database ...
- 2013 Oct 05