Chiedu Victor Nwosu
Quality Assurance Auditor at BioAgilytix- Claim this Profile
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Bio
Credentials
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Outlook: Efficient Email Management
LinkedInMar, 2021- Nov, 2024 -
Remote Work Foundations
LinkedInMar, 2021- Nov, 2024 -
Building Resilience
LinkedInFeb, 2021- Nov, 2024 -
How to Train Your Brain For Happiness
LinkedInFeb, 2021- Nov, 2024 -
Microsoft Teams Essential Training
LinkedInFeb, 2021- Nov, 2024 -
Migrating from Skype for Business to Teams
LinkedInFeb, 2021- Nov, 2024 -
Communicating with Confidence
LinkedInJan, 2021- Nov, 2024 -
Quality Management Foundations
LinkedInDec, 2020- Nov, 2024 -
Time Management: Working from Home
LinkedInDec, 2020- Nov, 2024 -
Project Management Foundations
LinkedInSep, 2020- Nov, 2024
Experience
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BioAgilytix
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United States
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Biotechnology Research
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700 & Above Employee
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Quality Assurance Auditor
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Aug 2021 - Present
• Perform Quality Assurance (QA) audits, inspections (internal/external) and monitoring procedures against standard operating procedures, methods, protocols/plans, guidances, and/or regulations, as applicable • Issue QA statements for reports as needed • Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as required • Assist in writing and reviewing QA standard operating procedures • Positively impacts the company through successful contributions, active participation and identification of compliance gaps • Obtain and maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks • Assist in document management activities • Perform duties with minimal QA Management oversite Show less
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knoell
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Germany
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Environmental Services
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200 - 300 Employee
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Quality Assurance Auditor
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Jun 2020 - Jul 2021
•Performing facility and critical phase audits. •Reviewing reports, notebooks and data tables for compliance with GLP. •Working with other Quality Assurance staff to ensure reporting accuracy. •Advising staff on GLP policies. •Developing and maintaining strong communication and working relationships with internal and external teams. •Performing facility and critical phase audits. •Reviewing reports, notebooks and data tables for compliance with GLP. •Working with other Quality Assurance staff to ensure reporting accuracy. •Advising staff on GLP policies. •Developing and maintaining strong communication and working relationships with internal and external teams.
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Auditor
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Oct 2017 - Dec 2019
• Compiles Environmental Monitoring Data and conducts routine audits of data, information, procedures, equipment and systems (including computer systems) to ensure the compliance with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMPs), GLP, GDP and other applicable worldwide regulations. • Review and approve production documentation accompanying the release of filled vials to ensure conformance to appropriate site procedures in GLIMS, (approval done through SAP). Creation of sample plans and transcribing sample data from data sheets into GLIMS due to transcription events that may occur among operation’s personnel. • Communicates and resolves audit comments with Operation areas. Issue reports summarizing deficiencies and work with areas to execute remedial action. Notify appropriate management of atypical results and deviations from SOPs. Performs routine record repository of the completed document reviews. • Provides line clearances through manufacturing facilities. Close out incursions and reviews and approves RT Reports. • Aseptically qualified to gown in all areas within the manufacturing facilities. Show less
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Tergus Pharma
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Scientist 1
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Oct 2016 - Oct 2017
• Carried out laboratory work as directed by senior laboratory personnel. • Conducted routine analytical experiments using established analytical methods and procedures, including in vitro release testing technique, performed in GMP and GLP environment. • Participated in the development of analytical methods. • Wrote experimental methods toward various projects. • Assisted with assembling data summaries. • Participated in management of various projects, interacting with clients. • Created and managed purchase orders for required laboratory materials needed. • Data entry into spreadsheets. Verified simple transcription processes, such as reviewing peak areas entered from chromatograms through Empower into spreadsheets. • Reviewed and maintained laboratory notebooks and data packs for quality assurance purposes. Show less
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Sandoz
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Control Chemist 1
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Oct 2015 - Oct 2016
• Supported operations by providing analytical testing for materials and products, including data. • Performed dissolution, assay, content uniformity, related compounds/impurity analytical testing using HPLC (both Waters and Agilent systems) and UV. • Testing was performed in a GMP and GLP environment, primarily testing solid oral dosage forms (tablets and capsules). • Audited work performed by other QC Chemists. Work included analyzing data from dissolutions and Assay/CU. • Generated GMP documentation in support of the testing performed through Empower. Data was reported to LIMS. Show less
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UNC-Greensboro
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Greensboro/Winston-Salem, North Carolina Area
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Greenhouse and Laboratory Technician
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Aug 2014 - May 2015
• Performed specific tasks such as DNA extraction from Arabidopsis lyrata plant tissue, transplanting, routine collection of plant samples and plant siliques, sowing seeds, photographing plants, data entry and the use of Microsoft Excel, measuring of plant diameters and lateral shoots, plant crossing among different families, tagging identification of plants, lifting heavy objects at times, also fertilizing and watering plants on a routine basis. • Performed laboratory duties such as working with solutions, preparing cell cultures, microscopy and the examination of living and fixed cells. • Gained several months of experience examining extracted plant tissue under a confocal microscope. Centrifugation of substances, use of Agarose gel and tracking dye to perform PCR amplification on sample DNA. Show less
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Lake Lynn Community Center
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Raleigh-Durham, North Carolina Area
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Fulltime Counselor
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Jun 2011 - Aug 2014
Assisted participants with various activities at Lake Lynn Community Center. Assisted participants with various activities at Lake Lynn Community Center.
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Education
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2010 - 2015
UNC of North Carolina at Greensboro
Bachelor of Applied Science (B.A.Sc.), Biology
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