Quality Assurance Control

RACHELLA D. DOBSON

UNITED STATES * 919-***-**** * **************@*****.***

PROFILE

A well-established management level candidate with vast knowledge in pharmaceutical manufacturing that spans across multiple disciplines: Research, Product development and new product launch; Testing and Data Analysis, Product Validation, Investigations / Deviations, Quality Assurance, Quality Control, Project Management, Process Development, Engineering, Equipment Validation, and Staff Training \ Development. Over 11 years of Leadership experience. Over 9 years of Sterile experience in research, testing and manufacturing. Over 3.5 years of OSD experience in lab testing and manufacturing. Candidate has excellent skills in communication, collaboration, and organization across each of the aforementioned disciplines. She is well-versed in writing, documentation and excellent pharmaceutical/cGMP/GLP/ laboratory knowledge.

•Senior Validation Consultant with extensive experience in lab and manufacturing line equipment. Served as a validation project lead driving engineering and validation teams.

I.Supported Validation and Qualification of Lab Equipment. Strong experience in Lab roles organizing laboratory equipment, materials; maintaining and validating safety equipment, and performing maintenance on laboratory instrumentation.

II.Extensive experience in performing IQ/OQ and decommissioning procedures, establishing validation standards, developing testing protocols, preparing equipment, documenting test results, and developing validation requirements and specifications.

III.Coordinating Validation with internal teams and external vendors, generating reports/ documents, and reviewing processes. Assisted with Validation of spectroscopic instruments and tensile testing equipment.

IV.ISO audit preparation.

V.Drafting maintenance and calibration plans; collaborating with quality teams during the development of validation protocols/ reports; and coordinating/ overseeing vendor installation and testing to verify requirements and specifications are met.

VI.Authoring Validation Documentation, supporting Qualification runs, Validation Executions of lines, and QA with documentation and support materials.

•Project Manager experience leading commercial technical transfer of products (vaccine adjuvant).

I.Commercial technical transfer of products (vaccine adjuvant) onto site.

II.Developing SOPs for equipment; supporting the development procedures on aseptic process lines; authoring documents and revising documents.

III.Collaborating with production, validation and engineering departments in order to facilitate cGMP production of pharmaceuticals.

IV.Reviewed and validated quality requirements for manufacturing planning, supplier purchase orders and engineering specifications to meet contract compliance regulations.

V.Communicate with clients to review contracts, answer questions and determine special circumstances. Performed routine maintenance and calibration on testing equipment.

VI.Co-author work orders for vaccine, peer reviewed and served on team for Change Control.

•QC / QA competencies include, but are not limited to Performing Deviation and Investigations for both lab and manufacturing.

I.Address non-conformance issues and pausing production to correct errors.

II.Promoted adherence to quality standards by educating personnel on quality control.

III.Performed Root Cause Analysis (RCA) to identify and fixed issues due to investigations and to improve workflows.

IV.Establish Corrective Actions and Preventive Actions (CAPAs): 5 Whys, Fishbone diagrams, Triage with multiple internal departments to perform RCA and establish CAPAs, Write investigations and deviation

•Demonstrated managerial skills achieving a highly productive workforce. Well-developed skill set for developing people from different cultures, social and economic levels and education levels to work together as a team. By promoting respect and ensuring that each individual understands and know what is expected of them.

•Education Department Head - Developed students, teachers and administration

Supervised and mentored junior scientists in both research and industrial settings, aiding in character, team and professional development.

People Skills - Personnel development of others through team building, problem solving, multi-tasking, flexible, communication (speaking, listening and writing).

ACHIEVEMENTS

•Vendor Collaborations resulted in over a $100,000 saving for the company

•Testing standard project resulted in an increased test efficiency for the preparation of a micellar based standard. A 10% increased right first time for analytical runs, a reduction in analyst error investigations, and a 20% increase for high through put of product.

TECHNICAL COMPETENCIES

•Validation Engineering, Protocols, Technical Writing, Requirements Development

•GLP/ cGMP, Laboratory Equipment/ Systems, Pharmaceutical Manufacturing Systems

•IQ/ OQ/ PQ, Validation Documentation, Validation Testing

•Physical Chemical & Analytical Methods of Analysis

•Attenuated Total Reflection-FTIR Spectroscopy

•HPLC • GC • LC/MS/MS • LC/Ion-Trap Mass Spectrometry • AA Spectrometry • UV-Vis Spectrometry •

•Temperature Modulated Differential Scanning Calorimetry

•Raman Spectroscopy • MALDI-TOF Mass Spectrometry • Protein NMR • Dissolution

•Moisture Titration • TLC • Protein Purification • Peptide Analysis

SOFTWARE

•Trackwise

•SAP

•Microsoft Office

•Macintosh OS X

•Unix/Linux Operating Systems

LANGUAGE

•English

•Basic Spanish

PROFESSIONAL EXPERIENCE

QA Specialist III (Steriles), THERMO FISHER; Greenville, NC - Aug. 2022 - Present

Release batch records for Sterile product

Validation/Consultant (Steriles), PFIZER; Rocky Mount, NC - June 2017 – Aug. 2017

Provide support for engineering and validation teams for the serialition of packaging lines.

·Author Validation Documentation.

·Support Qualification runs and Validation Executions of lines.

·Support QA with documentation and support materials.

Validation SME/Consultant (OSD), PATHEON; Greenville, NC - Aug. 2016 – May 2017

Provide validation support to OSD (Oral Solid Dosage) department including:

·Generate appropriate documentation

·Provide support for GMP audits

·Support length of process for OSD validation

I.Participate in group meetings discussing new products and processes

II.Generate data to define the drug manufacturing process that is being validated

III.Generate reports summarizing events leading to completion of the process

Lab Analyst/Consultant (OSD), DSM PHARMACEUTICALS INC; Greenville, NC - Jan. 2014-May 2014

·Performed physical and chemical analyses on proprietary drug products according to international pharmacopeia; also responsible for calibration and troubleshooting lab instrumentation, our metrology.

·Consult on different projects.

·Organized and directed team building exercises at group meetings to help build critical thinking, problem-solving, and working together skills.

·Assist with transition to new company.

·Generated analytical methods to help standard and sample stability and robustness.

Validation Associate/Consultant (Steriles), BECTON-DICKINSON (Infotree Services); Wilson, NC - Mar. 2013 - Aug. 2013

·Responsible for supporting staff with Validation of production lines and plant at Becton-Dickinson.

·Assist with cleaning Validation of compounding and filling lines, and products run on the pre-filled syringe lines.

·Assist with the Validation of gas lines to production.

In-Process Quality Associate (OSD), SANDOZ-DIVISION OF NOVARTIS; Wilson, NC - Oct. 2012-Nov. 2012

·Accountable for assuring pharmaceutical agents are produced according to the appropriate pharmacopeia, company standards, and within assigned parameters.

·Work with manufacturing and the Quality Department to assure appropriate production and testing for the company's generic lines of product.

·Performed Gemba walks.

Chemist (OSD), MERCK MANUFACTURING DIVISION; Wilson, NC - May 2012-Oct. 2012

·Perform physical and chemical analyses on proprietary drug products according to international pharmacopeia regarding stability testing.

Project Manager/Consultant, CHAZON BIOVECTORS INC; Greenville, NC - 2011-2016

·Responsible with assisting with the startup of a new biotech company.

·Organize meetings with building and laboratory realtors for operating space.

·Perform potential site audits concerning location of possible facilities.

·Structured the overseas division to incorporate necessary skill base and capital.

·Create dialogue between the company and venture capitalists.

·Assist with procuring grant funding and consultants for grant writing.

·Coordinated efforts to finalize administrative components and monetary security.

·Responsible for staffing efforts including analyst, consultants and management staff.

Lab Analyst III (OSD / Metrology), DSM PHARMACEUTICALS INC; Greenville, NC - 2010-2012

·Supervised, trained, and mentored analysts on lab equipment calibrations, coordinated with validation and engineering for equipment setup of a Client specific lab, provided safety procedure training to the client while onsite for viewing the lab, and collaborated with upper management to ensure timely equipment implementation and mitigated any issues

·Performed physical and chemical analyses on proprietary drug products according to international pharmacopeia.

·Responsible for calibration and troubleshooting lab instrumentation.-Metrology.

·Helped improve methods for instrument calibration systems.

·Performed Gemba walks.

Senior Scientist-Project Management (Steriles), DSM PHARMACEUTICALS INC; Greenville, NC - 2009-2010

·Managed and oversaw both the internal and external project components to maximize and satisfy new client’s needs.

·Responsible for commercial technical transfer of products onto the site; managed logistical and shipping functions for customer projects.

·Assisted with the successful technical transfer of a vaccine adjuvant.

·Developed SOPs for manufacturing equipment.

·Worked directly with the manufacturing department to assure proper production of vaccine.

·Coordinated sample shipments.

·Collaborated with production, validation and engineering departments in order to facilitate cGMP production of pharmaceuticals.

·Assisted with development procedures on aseptic process lines.

·Revised and authored manufacturing documents.

·Facilitated production efficiency improvements through collaborative input of all group members and supervision.

Quality Laboratory Associate, DSM DYNEEMA; Greenville, NC - 2007-2009

·Served as a Safety Lead. Performed inspections of worksites to ensure that standard safety requirements were maintained. Collaborated with upper management to develop safety improvements for the employees, and to gain additional equipment needed to not only improve the work environment, but also to improve the proficiency of the team.

·Assisted with Validation of spectroscopic instruments and tensile testing equipment.

·Facilitated production efficiency improvements through collaborative input of all group members and supervision.

·Assisted with Root Cause Analysis (RCA) regarding deviations resulting from testing and was involved with ISO audit preparation.

·Accountable for assuring yarn material was produced according to company standards, and within assigned parameters.

·Performed routine testing and analysis of water from plant systems to determine if any VOCs from the process were present.

·Performed tensile testing, size analysis and draw tests of yarn to verify its capacity, and to assure results were within the allowed parameters.

·Performed spectroscopic analysis of yarn to determine the amounts of residual raw materials within the finished product.

Laboratory Technician (Steriles), AERIE PHARMACEUTICALS; RTP, NC - 2006-2007

·Accountable for the organization of laboratory equipment, materials and the liquid formulation of novel pre-clinical drug compounds.

·Designed various liquid formulation strategies and developed methods for screened compounds of a drop dose system.

·Developed the company's chemical inventory system.

·Responsible for maintenance and Validation of safety equipment.

·Performed method development with LC/MS.

·Performed maintenance on laboratory instrumentation.

Department Head, DUPLIN COUNTY SCHOOLS; Rose Hill, NC - 2005 - 2006

• Managed Teachers in accordance to organizational rules and incorporated policy changes into day-to-day activities, evaluated their performance to identify areas of improvement and developed creative strategies to keep them on track, and served as a mentor to new teachers

• Responsible for teaching students science according to the North Carolina Department of Instruction guidelines and supervising the science teaching staff.

• Taught 8th grade according to the NCDPI’s curriculum guidelines.

• Science Department Head-managed staff of six

• Collaborated with teachers and administrators in development, evaluation and revision of school programs.

• Empowered students through counseling and skill-building exercises.

Research Intern VI (Steriles), WYETH VACCINES; RTP, NC - 2004

·Supervised and developed junior scientists: instrumental skills, specimen analysis, and training. Obtained needed resources by strategically negotiating with outside suppliers.

·Assisted in research of novel vaccines, and their delivery systems.

·Worked with method development of simple protein purification schemes.

·Developed a method of purified protein analysis on HPLC.

·Collaborated with the formulation department, helping with operation and maintenance of the Differential Scanning Calorimeter.

·Authored reports concerning each process step of the research.

·Worked with vendor equipment personnel to assure instruments were properly validated and functioning.

Research Associate / Graduate Student (Steriles), NORTH CAROLINA STATE UNIVERSITY; Raleigh, NC - 1998-2004

·Managed and taught chemistry classes and laboratories at all levels offered within the department Responsible for laboratory equipment, setup and maintenance

Helped students to develop organizational, time management, and study skills

Encouraged and taught students how to focus on their prospective goals, and how to overcome obstacles by providing them with problem solve techniques; to logically deduct the best path forward

·Accountable for research in the areas of physical and analytical chemistry, and chemistry instruction.

·Conducted research into the folding and unfolding properties of proteins using various physical-analytical and thermal methods.

·Authored a dissertation based on this research.

·Attended several scientific conferences, and presented research.

·Worked with Pharmaceutical company to make HIV pharmaceutics.

PUBLICATIONS

·L.M. Kraus, R.D. Dobson, J.C.W. Folmer, C.A. Haney, M. Steeves, S. Franzen. Renal Insufficiency and Urea-Derived Cyanate: Carbamoylation Irreversibly Disrupts Protein Folding Altering Structure J. Am. Soc. Nephrol 15:534A, 2004

·"Quantitative Analysis of Gold Nanoparticles with Atomic Absorption Spectroscopy" in progress

·Dissertation: "Probing the Unfolding Properties of Lysozyme and Bovine Serum Albumin Under the Influence of Urea and Guanidine Hydrochloride with Temperature Modulated Differential Scanning Calorimetry, Mass Spectrometry, and Fourier Transform Infrared Spectroscopy."

EDUCATION

·A.B.D. Gradate Work, Physical Chemistry, North Carolina State University, Raleigh, NC

·Bachelor of Science, Biochemistry, North Carolina State University, Raleigh, NC

·Bachelor of Arts, Chemistry, North Carolina State University, Raleigh, NC

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