Quality Control Project Management

SENIOR QA AUDITOR

(Quality Control, Method Development/Validation/Qualification/Transfer, Data Integrity, GMP Compliance & Investigations, Analytical Project Management, Quality Audits, Technical Writing of GMP Documents)

Robert Yawadio Nsimba

5840 McCrimmon Parkway, Unit 312, Morrisville, NC 27560

-USA-

Tel: (1-443-***-**** E-mail: ******.******@***.***

Objectives

A Senior Chemist seeking a Lead role in Quality Control/Assurance & Analytical Project Management within a GMP working environment.

HIGHLIGHTED SUMMARY OF QUALIFICATIONS

Experienced to work in a GMP regulated environment, with supervisory and training skills set mainly on the use of the analytical instrumentation, with regulations, data integrity and GMP Investigations for Quality Control Lab Data & Manufacturing Batch Records. Highly skilled in routine analysis and method development/validation of API, in-process and finished products using LC and GC analytical systems monitored with Empower 2/3 and analytical activities recorded in hardcopy or NuGenesis electronic notebook. Solid understanding of various compendia guidelines (USP, EP, JP, ICH) and Technical writing of SOPs, Protocols, and Reports associated with analytical methods and audits.

Ability to troubleshoot LC and GC apparatuses, and other laboratory equipment. Highly skilled in reviewing ANDAs and batch records to detect issues relating to good documentation and laboratory practices including compliance and data integrity issues, assess their impact on product quality, determine the root cause and define efficient CAPA for remediation.

IQ, OQ, PQ Process: Applied in lab analytical equipment and software to certify with documented evidence that the EQ/Software received has been properly installed according to manufacturer’s instructions, verified that its functionality meets manufacturer’s specifications, verified that the system can perform effectively and reproducibly ensuring the accuracy and precision of testing results.

Ability to multi-task and on-time deliver

Support regulatory changes through the provision of necessary validation documentation and change control activities and write summary reports during regulatory inspections and internal audits Provide hands on support to formulation and manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements. Collect and analyze data to make data driven recommendations/decisions.

Use scientific and GMP background to understand the technical aspects of daily quality control challenges and create strategies consistent with the operational and compliance needs.

Build and maintain successful cross-functional relationships with other departments and locations of the company to promote global economic growth of the company

WORK EXPERIENCE

Aseptic Techniques Coach 08/2023 to 12/2023

Pfizer (Rocky Mount, NC)

Monitor, teach, and enforce best and proper aseptic practices/techniques within drug product filling manufacturing areas.

Perform routine observation duties of the aseptic operation to ensure compliance in alignment with site SOPs, best practices, and regulations.

Train new and existing employees on aseptic principles and coach them on expectations for sterile manufacturing.

Managae change controls (process improvements) due to procedures not followed in general aseptic techniques/behavior in the aseptic core or the isolator filling room.

Senior Quality Assurance Auditor 02/2022 to 07/2023

Catalent Pharma Solutions (Morrisville, NC)

Audit a variety of methodologies as applied to various stages of pharmaceutical development.

Write audit report to communicate to magament findings of non-compliance, non-conformity, and performance issues.

Verify accurate transcription of raw data into reports.

Audit analytical deliverables for their compliance to specifications from applicable SOPs, quality standards, and regulatory requirements.

Discuss issues with lab staff as discovered during final report auditing, laboratory walkthroughs or other internal audits.

Identify potential compliance issues and initiate as applicable change controls, process improvements, and/or corrective measures to prevent their re-occurrence.

Prepare the site to customer’s and FDA audits, and participate in preparing responses to various audit findings.

Actively contributing to the Deviations Review Committee (cross-functional group meeting): mainly focusing on deviation initiation, trending analysis, metrics, and RPN score to determine either minor or major. Investigation-type, conduct and/or review investigations, root cause analysis and CAPA development and their effectiveness check, technical writing of the deviation reports and their review, their approvals and closure of CAPA and effectiveness checks.

Lead Quality Specialist 11/2020 - 01/2022

Catalent Pharma Solutions (BWI Harmans, MD)

Maintain and administer quality systems including document management, investigation/deviations, CAPA tracking, risk management, quality metric tracking, training and other quality systems. Interface and communicate with the Client, Analytical Development teams, Technology Transfer group and the BMP Manufacturing departments in meeting project timelines, providing deliverables and resolving issues. Perform quality review of Analytical Development documentation including raw data, test methods, protocols and executed method qualification reports. Support external client audits. Perform periodic walkthrough audits of Analytical Development and Quality Control laboratories. Implement continuous improvement initiatives. Provide quality oversight of process and analytical method development in an R&D setting for client projects. Provide quality oversight in compliance with GMPs for Quality Control testing of clinical product.

Manufacturing Specialist 08/2019-10/2020

Catalent Pharma Solutions (Baltimore, MD)

Initiates Quality Records and conducts deviation investigations, including product impact assessment and risk analysis, root cause analysis and CAPA development and their effectiveness check. Support Tech transfer and process monitoring support as needed, Leads or supports Continuous Improvement project. Conducts data gathering, trending, and data presentation as needed to support investigations. Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.

Global Quality Control Senior Compliance Specialist 11/2018-07/2019

AKORN Pharmaceuticals, (Somerset, NJ)

Address GMP, Compliance and Data Integrity issues found in routine tests, stability studies and method development and validation tasks performed in QC/R&D Labs (from ANDAs & Batch Records), assess their product impact, the root cause and suggest the adequate CAPA for remediation

Senior Instrumentation Chemist 10/2016-11/2018 SGS North America, (Fairfield, NJ)

Supervision of Daily Analytical Activities of the Instrumentation Team and Technical Training on new analysts in the use of HPLC and GC systems and the Empower 3.0.

Routine analysis of API (small molecules. And HMW molecules), drug substances and food products using HPLC and GC with the use of Empower. Method development and validation on impurities and drug substances. Training of new users of LC and GC systems.

Team member of the Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ) or Instrument Performance Verification (IPV) Services for the site.

ARD Chemist 04/2014 –10/2016

TEVA Pharmaceuticals (Pomona, NY)

Routine analysis of API and drug products using Waters UPLC, HPLC Method development, the use of Empower and NuGenesis electronic notebook under GMP environment.

Training of new analysts on the use of UPLC, Empower 2.0, and basics of method development

Research Chemist 08/2013 –03/2014

PINOVA, Inc. (Brunswick, GA)

Pinova/Ensyn Joint Project

Overall Management of the Joint Project Pinova/Ensyn on Pyrolysis Oil.

Method development for the characterization of lignin-derived asphalt emulsifiers via chemical modifications, and HPLC and GC profiling (ID Test) of value-added chemicals from Pine lignin.

VisitingResearch Scientist 02/2012-07/2013

USDA-ARS-ERRC (Wyndmoor, PA)

Supervisory role on the Conversion Team of the Farm-Bio Project.

Method development for the analysis of sustainable co-products chemical intermediates derived from lignin;

Set up of new or existing analytical methods for identifying compounds, performed thermal hazards testing, coordinated off-site testing as necessary and conducted testing of analytical samples for the Chemical Department.

Research Associate 07/2010-12/2011

National Research Council Canada (Ottawa)

Developed and validated analytical test procedures.

Performed test method transfers.

Gained extensive knowledge of scanning electron microscopic techniques.

Worked in a cGMP laboratory with strong emphasis on HPLC, spectroscopy and

data handling.

Visiting Fellow 2009-2010

Pacific Agri-Food Research Centre, Summerland, BC (Canada)

Conducted research and deepened expertise in the Chemometrics, multivariate analysis and FT-IR

prediction of lignin content in straws, developed a micro-scaled acetyl bromide method to quantify

lignin in plant materials. Supervised co-op students, regulated and manipulated various analytical

equipment (e.g. HPLC, UV/VIS Spectrophotometer, GC-MS, ATR-FTIR, Oven, Microwave, etc)

Developed and wrote new analytical methods

Created new ways of finding targeted components within organic and non-organic matter

Developed chemometric multivariate FTIR prediction methods to determine biopolymers and extractives content in raw materials

Gained extensive knowledge of wet chemical methods

EDUCATION

April 2004-March 2006: Master in Food Chemistry (emphasis on anthocyanins, extraction, structure elucidation, development & Validation of analytical methods, and biological activities)

Osaka Prefecture University (Osaka, Japan)

Sept. 1994-Oct. 2000: Bachelor’s in chemistry and Agro-Industries (emphasis on oil bleaching using activated carbons)

University of Kinshasa (Kinshasa, D.R. Congo)

CONFERENCES ATTENDED

October 28-November 2, 2012: Pittsburgh, PA USA. The 2012 AIChE Annual Meeting. Physicochemical Properties of Pyrolytic Lignins Derived from Fast Pyrolysis of Etek Lignin. p. 356

November 30, 2007: KYOTO, Japan. International Conference on Food Factors for

Health Promotion. Poster presentation with the abstract title: Three new minor

ecdysteroids isolated from Chenopodium quinoa, their antioxidant and collagen

inhibitory activities

November 18, 2007: HIROSHIMA, Japan. Japanese Society of Nutrition and Food

Science. Oral presentation with the abstract title: Two new flavonol glycosides isolated

from the seeds of Chenopodium quinoa

March 27, 2006: KYOTO, Japan. Japanese Society of Bioscience, biotechnology and

Agrochemistry. Oral presentation with the abstract title: Acylation of anthocyanin

glucosides as a tool for their color enhancement and stabilization. p. 27

October 1, 2005: OSAKA, Japan. Japanese Society of Bioscience, biotechnology and

Agrochemistry. Oral presentation with the Abstract title: Study of pigmented rices

(Oryza sativa L. Japonica) as multifunctional ingredients. p.12

August 25, 2005: SEOUL, South Korea. The 11th Asian Chemical Congress

Program. Oral presentation with the title: Structure elucidation of phenolics isolated

from black and pigmented brown rices

November 20, 2004: OSAKA, Japan. The international colloquium on plant

biotechnology (Further progress in productive and sustainable agriculture), Japan

Society for Bioscience, Biotechnology, and Agrochemistry. Osaka Prefecture

University. Poster presentation with the title: Study on phenolic compounds from black

and red rices (Oryza sativa L. japonica) p.23

PUBLISHED WORKS

(1) ACS Sustainable Chemistry & Engineering.

Structure-Property Characteristics of Pyrolytic Lignins Derived from Fast Pyrolysis of a

Lignin Rich Biomass Extract. 2013, 1, 260−267

(2) ACS Journal of Agricultural and Food Chemistry.

Structure and Radical Scavenging Activity Relationships of Pyrolytic Lignins. 2012, 60,

12525−12530

(3) American J. Anal Chem.

Determination of Lignin in Crop Straw Materials by the Acetyl Bromide Method and ATR-

FTIR Spectroscopy. (Accepted).*

(4) Polymer Journal

Lignin Variability in Physicochemical Characteristics and Antioxidant Properties upon

Thermoconversion of Lignocellulosic Biomass Feedstock. (Revised)

(5) J Biochem Mol Toxicol

Ecdysteroids Act as Inhibitors of Calf Skin Collagenase and Oxidative Stress. 2008, 22 (4),

240-250.

(6) Food Chem.

Antioxidant Activity of Various Extracts & Fractions of Chenopodium quinoa and

Amaranthus spp. Seeds. 2008, 106 (2), 760-766

(7) Food Chem.

Color Enhancing Effect of Carboxylic Acids on Anthocyanins. 2007, 105 (1), 421-427

(8) Food Chem.

Identification of Phenolic Compounds Isolated from Pigmented Rices and Their Aldose

Reductase Inhibitory Activities. 2007, 101 (4), 1616-1625

*References available upon request.

Robert Yawadio Nsimba

Employee ID: 905741

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