With work experience over 17 years, Beckinam is now working at Synthego Corporation which is based in 1067 as a Director of Quality. Beckinam received his education from 2018 to 2022 at the Loyola Marymount University. This person is a proven expert, that is proven by qualifications : Regulatory Affairs Certified, Regulatory Affairs Professionals Society (Raps), and Certified Biomedical Auditor (Cba). Beckinam Nowatzke speaks Arabic fluently. Beckinam Nowatzke can be found in Austin, Texas. To contact directly Beckinam, you can look for their phone number or e-mail or find full info by requesting access to this expert's additional details on this webpage.
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Beckinam Nowatzke
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Workplace
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Work History
Director of Regulatory Compliance and Clinical Reearch at Wenzel Spine
1130 Rutherford Ln SUITE 200, Austin, TX 78753
Responsible for strategic management, improvement, and implementation of the Wenzel Spine and IsoStem Quality Systems & Regulatory submissions. This role is also engaged in clinical affairs,...
Feb 1, 2015 — Nov 2018
Advisor, Qa and Ra Services
29 east Mccarty St SUITE 100, Indianapolis, IN 46225
Leading client projects to support product development, submissions, and post-marketing activities across multiple therapeutic areas and regulatory authorities by: Creating, evaluating, and ...
from Oct 2018
Senior Manager, Us Quality Affairs
13785 Research Blvd SUITE 200, Austin, TX 78759
Built and lead the growth of the Quality System throughout LDR Spine as it grew from a company of 35 to over 200 people. Responsibilities included expansion and integration of quality system...
Dec 2009 — Feb 2015
Quality Improvement Supervisor
Developed/implemented an in-process inspection program; Conduct inspections of clinical study conduct processes in real-time; Created/maintained inspection schedule.
Perform Quality Assura...
Feb 2008 — Dec 2009
Manager, Quality Assurance and Compliance
389 Nichol Mill Ln, Franklin, TN 37067
Management of all Quality Assurance activities for on-going Orthopedic and Orofacial clinical trials
CRO qualification
Internal record, external supplier, and investigative site GCP audit...
Aug 2007 — Feb 2008
Compliance Manager - Glp
1 Amgen Center Dr, Thousand Oaks, CA 91320
Conduct audits or inspections in support of GLP preclinical or regulated clinical studies
Write and distribute audit reports
Dedicated department PKS Report LIMS representative
May 2005 — Aug 2007
Senior Associate, Pharmacokinetic and Drug Metabolism
1 Amgen Center Dr, Thousand Oaks, CA 91320
Performed noncompartmental and compartmental pharmacokinetic analysis using WinNonlin
Wrote and distributed preclinical (non-GLP and GLP) and regulated clinical reports in the Oncology The...
Oct 2001 — May 2005
Education
2018 — 2022
2006 — 2010
1996 — 2000
Occupations
Executive
Director
Sales Specialist
Supplier
Operations Manager
Services Professional
Sales Representative
Skills
Fda
Medical Devices
Capa
Quality System
Validation
Glp
Clinical Trials
Biotechnology
Quality Assurance
Gcp
Regulatory Affairs
Gxp
21 Cfr Part 11
Cro
Sop
Iso 13485
Ind
Laboratory
Lims
Quality Management
Computer System Validation
Cross Functional Team Leadership
Trackwise
Quality Auditing
Ce Marking
Design Control
Supplier Quality
Continuous Improvement
Compliance
Software Validation
Change Control
Sop Development
Pharmacokinetics
21 Cfr
Clinical Development
Drug Development
Quality Systems
Auditing
510 K
Qsr
Complaint Handling
Inspection
Audit
21 Cfr Part 820
21 Cfr Part 58
Informed Consent
Orthopedic
Root Cause Analysis
Quality Control