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Resumes 41 - 50 of 109 |
Bristol, PA
... Conduct, manage investigations, OOS, OOT, OOAL and draw conclusion as well as CAPA. Represent the group in meetings with scientific, technical, regulatory, research and development, product development. Analytical method development and validation ...
- 2020 Apr 27
Bristol, PA
... SKILLS Quality Skills Software Skills SOP writing TrackWise Deviations, CAPA Document Management Systems Root Cause Analysis Batch Record Review and Batch Release iLIMS Material Management System Minitab MS Office Electronic Batch Record System ...
- 2019 Jul 02
Lawnside, NJ
... Good fundamental understanding of CAPA, deviation, change control, root cause analysis, and Quality System Regulations, such as 21 CFR 820, 21 CFR 803, and ISO13485 Understanding of the FDA meeting requests, conduct of the Clinical trials, ...
- 2019 Apr 22
Mount Laurel Township, NJ
... update business partners and supporting staff on contracting compliance 7.Comply with request from QA and auditors ●Maintain CAPA Tracker: 1.Maintain and manage Internal JRP CAPA Tracker ●Approved Supplier List for Client: 2.Facilitate Client ASL ...
- 2019 Jan 04
Norristown, PA
... Schedule and perform rework when required, and write CAPA reports to document the corrective actions and the preventive actions. Perform administrative duties such as training new hires and remedial training of tenured employees, times, performance ...
- 2018 Oct 31
Media, PA
... Supported audit activities, implementing Corrective and Preventive Action (CAPA) system review and analysis of complaints. Recommended remediations to FDA, ensuring compliance with current FDA/QSR, ISO13485, CE Marking, and other appropriate product ...
- 2018 Sep 28
Philadelphia, PA
... • Performed CAPA for the defects in devices, studied SOPS and prepare statistical data reports using FMEA. ACADEMIC PROJECTS Ultrasound Wound Healing Device – Biomedical Entrepreneurship Project Jan 2017 – April 2017 • Identified the 21 CFR 820 and ...
- 2018 Aug 14
Newtown Square, PA, 19073
... ● Support CAPA activities, root cause analysis, and non conformance investigations. ● Develop and validate appropriate test methods to asses product performance. ● Support development and execution of comprehensive quality strategies for process ...
- 2018 Apr 30
Philadelphia, PA
... Skills & Abilities cGMP, GLP, Aseptic & Supervisory Experience, IQ, OQ, PQ, Validation, SOP writing, Protocol and Report writing, CAPA, Lean Six Sigma trained, Gage R&R, FMEA, HPLC, TOC, EDMS, MS Office, Minitab 16. Experience Sr. Validation ...
- 2018 Mar 17
Clifton Heights, PA
... CORE QUALIFICATIONS • Customer / Field Service Management • Policy/Program development • Quality and Regulatory Affairs • FDA / TUV experience • Standards utilization • 510K Submissions • CAPA and Complaint Surveillance • Quality Management • ...
- 2018 Mar 15