SHEILA JONES

** ******** ***** *** #* OCEAN RIDGE, FLORIDA 33435

PHONE/ TEXT: (561) 703- 1753 EMAIL: adwblz@r.postjobfree.com

PROFESSIONAL OVERVIEW:

Currently serving as a Quality Assurance & Regulatory Consultant to pharmaceutical and medical device manufacturers. Specializing in the development of Quality Systems documentation, Quality compliance / regulatory assurance (FDA ISO, EU MDR cGMP) auditing, CAPA remediation and project management. Experience built upon scientific education and technical skills acquired via "Hands On" manufacturing process systems and product testing from the ground up from laboratory bench testing and test method development (TMV), process engineering (writing and executing equipment/ software/ systems validation and qualification packages). Procedural (SOP) development, modification and change management. Regulatory Compliance assurance (vendor/ supplier audits, GAP analysis, Risk Assessments) and (CAPA) corrective/ preventive actions remediation, project management tracking oversite.

* 10+ years experience in Quality Assurance/ Regulatory Compliance:

Developing / auditing Quality Systems documentation associated with Medical device and Pharmaceutical manufacturing processes to ensure compliance with FDA, EU, ISO, and MDD regulatory requirements [cGMP / GxP, GAMP5, ISO 13485, ISO 14644, ISO 9001, 21CFR part 11 (210/ 211) and 21CFR part 820]

* 8 years experience in Manufacturing Equipment Systems and Process Engineering :

supporting cGxP manufacturing processes equipment and systems. testing, qualification, process optimization and remediation through the development, execution and reporting of engineering studies, system/ limits testing, risk analysis, change impact assessments, design control, PFMEA, GAP analysis risk assessments and technical reports.

* 8 years experience in Project Management :

Coordinating, managing and balancing multidisciplinary project teams (including clients, suppliers, vendors, internal & external personnel and regulatory agents) to perform process development, equipment testing, and systems optimization.

Tracking, trending, scheduling coordinating and reporting critical project activities, personnel and deliverables. Fluidly realigning priorities, responsibilities and objectives in response to project developments and manufacturing/ production demands as necessary to meet project timelines.

* 12 years experience in Quality System Requirements (QSR) documentation:

Write, develop and review process/ system supporting documentation packages and standard operating procedures (SOPs) ensuring compliance with corporate, industry, and regulatory standards. Execute, analyze, trend, summarize and communicate Quality Control testing and process related technical data/ reports.

* Software (SDLC) training and experience : Microsoft Office suite (MS Word, Excel, Power Point, MS Word, Outlook, Visio, MS Project, MS Teams), LIMS systems, TrackWise, Documentum, LotusNotes, and Sharepoint applications in support of Lean Manufacturing and SixSigma methodologies

EDUCATION:

UNIVERSITY OF GEORGIA, Athens Georgia:

Degree: Bachelors of Science, Environmental Health Science (Minor: Food Science)

Degree: Bachelors of Science, Microbiology

QUALITY ASSURANCE / COMPLIANCE EXPERIENCE:

Manufacturing and Test Equipment Validation/ Qualification:

Installation Qualifications (IQ)

Operation Qualifications (OQ)

Process/ Performance Qualifications (PQ)

Design Engineering Studies

Automated Control Systems:

Building Management Systems (BMS) and Laboratory Information Management Systems (LIMS) installation qualification testing and upgrade.

Software and Computer Systems Qualification: Leveraging Software Acceptance Testing (SAT)/ Factory Acceptance Testing (FAT) in support of 21CFR part 11 compliance and manufacturers intended-use.

Project Management: Coordinating the construction and commissioning of Medical Device/ Pharmaceutical Manufacturing Facilities, Contract Laboratories and CleanRooms.

(CAPA) Corrective Actions/ Preventive Actions: review track audit remediate and document process/ procedural deviations, audit findings, Out of Specification (OOS) incidents and investigations.

Regulatory Assurance and Compliance oversite (ISO, GMP, GxP, AAMI, CE marking, FDA, EU- MDR): internal and vendor auditing, GAP analysis, Risk Assessments, CAPA generation and remediation

Quality System Requirements (QSR), Standard Operating Procedures (SOP) and Device History Records (DHR) development, compilation and correction.

Change Management Systems:

Change control management, process/ document modification and change notification. Coordination of cross-functional teams required to navigate Change Management System.

Design control documentation:

Device History Files (DHF), Quality Systems Records review [Work instructions (WI) and Standard Operating Procedures (SOP)], pFMEA, batch record review, Risk Assessments, impact assessments, and GAP analysis.

MANUFACTURING EQUIPMENT, SYSTEMS, PROCESS AND PROJECT ENGINEERING EXPERIENCE:

Sterilization Systems (gamma, gas and steam)

Industrial HVAC systems

Laboratory and chemical fume hoods

Sterile Air Handlers

Air Handling Units (AHU) / HEPA filtration systems

Computer Systems/ Software upgrade

Conveyor lines (Bosch)

Heat sealers

Cozzoli (capping/ filling) machines

Mix tanks/ BioReactors/ production systems and CIP skids

Water (WFI and RO) filtration systems

Packaging systems and photo systems

DCS & PLC Control Systems

S.A.T/ F.A.T (acceptance testing)

Autoclaves (EO) Ethylene oxide, gamma & steam

temperature mapping (KAYE and wireless dataloggers)

PREVIOUS CLIENTS:

GensiaSicor Biotech

Stryker Orthopedic medical devices

Allergan Biotech/ pharmaceutical

Pharmacia/ Pfizer Pharmaceutical

Medtronic orthopedic medical devices

Novartis (CibaVision/ Alcon)

Philips medical and electronic devices

Glaxo-SmithKline Pharmaceutical

Eli Lilly Pharmaceutical manufacturing

CREDENTIALS/ CERTIFICATIONS:

ASM (American Society of Microbiology) Certification- Registered Microbiology Specialist: biological safety & Industrial microbiology

ASTM Certification- ISO 9001 Internal Auditor

CDC (Centers for Disease Control) Certification- Primary Epidemiology

AAMI Certification- QSM (Quality Systems Management ) Quality System Requirements (QSR)

WORK EXPERIENCE:

QUALITY ASSURANCE ENGINEER AND COMPLIANCE CONSULTANT 2007 TO 2023:

Arthrex (Orthopedic Medical Device Manufacturing)- Naples Florida. October 2022 – April 2023:

Software Validations Engineer- Write and perform equipment and systems software testing and validation: leveraging User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Criteria (DC) and manufacturers intended- use specifications associated with orthopedic/ medical device production equipment (laser etching / injection molding machines) test inspection and measurement systems.

Writers Assistance Inc.- REMOTE May 2022- August 2022

Technical Documentation Specialist- Generate Quality System Records for a start up invitro- diagnostics (pharmaceutical) manufacturer. Establish standardized formatting of corporate requirements documents (QMS), product Batch Records, standard operating procedures (SOP), in-process inspection/ testing reports, and work instructions (WI). Migrate and consolidate existing records from 3- different electronic Document Management Systems (DMS) onto new (Documentum software) system.

Philip's (electrical/ Medical Device Manufacturing) - Boston Massachusetts. June 2019- April 2022:

Project Manager – CAPA resolution/ Trackwise System specialist.

Medical Device production process CAPA investigation/ remediation through Cross- Functional team coordination. Trackwise systems reporting of deliverables (failure analysis, Root cause analysis, risk assessments, engineering studies) timelines and accountability. Facilitate Document Change Control (modify review and approve (DHF) Device/ Design History Files (SOP) procedures, work instructions (WI) and other supporting documentation).

ZImmer Biomet (medical devices) - Warsaw Indiana. October 2018- June 2019:

Regulatory Compliance (CAPA) Remediation Project-

Perform medical device production process compliance investigations in response to FDA 483 warning letter. Coordinate Engineering and Documentation Change Control Process ( Device History Files, validation documents, SOPs etc) as needed to remediate regulatory compliance infractions.

Pfizer pharmaceuticals- McPherson Kansas. December 2017- october 2018:

Equipment validation Engineer/ project leader- 13 personnel.

Perform autoclave sterilization systems validation remediation testing. write and execute qualifications (IQ OQ PQ) in accordance with ISO 13485, FDA, EU- MDR and GxP requirements.

Nanotherapeutics (pharmaceutical contract laboratory)- Gainesville Florida January 2016- November 2017:

Quality Assurance and process development Project Manager- Coordinating the New (Dept. of Defense) contract laboratory facility Construction/Commissioning and equipment/systems validation. Coordinating project agendas and deliverables from multiple vendors up through corporate and accountable government agents. Direct oversite of 25 personnel. Coordinating, delegating and reviewing execution of work.

Alcon Novartis (Medical devices)– Atlanta, Georgia September 2014- December 2015:

Quality Systems Development and compliance Specialist- Develop and implement a corporate electronic Document Management System sconsolidation of redundant corporate procedures, Change Control project management coordinate the internal auditing functions, initiate procedural modifications, manage and track through the Change Control process and initiate training programs.

AMBU (Medical Devices)– Indianapolis, Indiana February- August 2014 :

Validations Engineer- Project Team of 24 personnel.

Vendor selection and qualification for Medical Device manufacturing (injection molding and extrusion) process. Develop and complete vendor qualifications packages. Review submitted documentation, perform GAP analysis and risk assessment, initiate engineering remediation in accordance with cGMP and ISO 13485.

Stryker (Medical Devices)– Lakeland, FL July 2013- January 2014 :

Validations Engineer (Medical Device reprocessing)- Coordinate project team of 16 personnel in Cleaning Method and functionalal Process development including Outsourced Sterilization vendor selection and quality standards/ records development. Process scale up to manufacturing, equipment/ process validation (design control, Validation Plan, pFMEA, risk assessments, Software and Computer control system qualification) supporting FDA 510K.

Noven Pharmaceuticals– Miami, FL Sept- June 2013 :

Software Validations (CSV)- 21CFR part 11 compliance. Coordinate systems testing/ validation of Pharmaceutical Manufacturing Automation (Computer systems and software ) upgrades, Ensuring process functionality retained and modifications documented in compliance with FDA and company policies/ operating procedures and regulations. Develop computer systems Validation Package deliverables including Validation Plan, Traceability Matrix, SAT/ FAT test protocols/ reports. Coordinate efficient roll- out of software patches and system modifications of legacy system across 3-manufacturing sites.

Hospira Pharmaceuticals – Rocky Mount, NC January- August 2013 :

QUALITY Audit Team Leader- remediation of pharmaceutical manufacturers backlog of unresolved Corrective and Preventive actions(CAPA) in response to FDA 483 warning letter. Review oversites, generate nonconformance reports via Trackwise software, Oversee the change control process ensuring thorough documentation of cross functional teams remedial efforts, corrective measures, efficacy of changes and CAPA closure.

Biomerieux Biologics– Durham, NC April 2012- december 2012:

Computer Systems Validation engineer- Assist in the pharmaceutical manufacturing operations validation (document writing and execution) of a new pharmaceutical product manufacturing suite including building management system (BMS) upgrades, COTS software validation, equipment validation, OOS/ excursions justification and APA (Corrective / Preventive actions.)

Medtronic Medical Device Manufacturers- Memphis, TN December 2010- March 2012:

Quality Assurance Consultant- FDA 483 remediation (medical device cleaning validations). Develop reprocessed medical device cleaning method and process qualification (associated w gamma irradiated medical devices). Assist in mediating identified device design inconsistency, corrective/ preventive actions, and justifications as they related final product sterility assurance and cleaning efficacy.

Stingray Surgical Instruments- Boca Raton, Florida January 2008- december 2010:

Project Manager- Medical Device corporate scale up/ facility transition to ISO9001 certification. Provide guidance on new FDA 483 regulated products including: documentation GAP analysis and Change Management. Institute company wide transition to electronic records maintenance and approval methodologies. Liason between governing regulatory expectations (FDA) and Client (medical device producers) application /enforcement; represent as clients Quality Ambassador during regulatory agency audits (ie: FDA and ISO) supporting communications, interactions, submissions and audit responses.

BIOTEST pharmaceuticals- Boca Raton, Florida May 2006-september 2007:

Technical Writer- Research and Author cGMP technical papers and website editorials (ghostwriter via home office) for various organizations such as, PDA (Parenteral Drug Association), Medical Device and Diagnostic Industries (MD & DI), American Society of Microbiology (ASM). Collaborated on presentations (powerpoint) at International Society of Pharmaceutical Engineers.

QUALITY ASSURANCE CONSULTANT & PROJECT MANAGER 2002 to 2007 (via Tracematrix Technical Staffing):

Develop and coordinate cross-functional multi-disciplinary Validations Project Teams. Prioritize and communicate timelines, personnel /resource requirements and assign accountability as necessary to optimize team functionality and ensure timely project deliverables to clients. Generate and review process and equipment validation protocols/ test methods / and supporting documentation project deliverables as reflected below:

SMITHS MEDICAL Inc – Keene, New Hampshire 2004 - 2005:

Prepare technical documentation pertaining to multiple equipment packaging lines for submittal to FDA and regulatory authorities. Write and review Standard Operating Procedures (SOPs), work instructions and specification forms. Maintain Quality System in compliance with ISO 13485 and 21 CFR part 820.

Coordinate the documentation Change Management of Medical device production process [SOPs, Engineering Design Studies, equipment qualifications (IQ OQ PQ CSV), risk assessment, Test Method Developent (TMV) ].

Execute Packaging validation protocols in accordance with corporate and regulatory guidelines (FDA, Eu, PMI, ANSI, ISO, AAMI)

Coordinate the synchronous execution of various validation teams, reporting and remediating project delays, milestones, schedules and responsibilities for multiple projects (15 people/ direct reports)

Technology Transfer and global harmonization of testing and documentation associated with the production line migration to UK and Mexico.

Oversee teams compliance and maintain project deliverables regarding Document Change Controls and communicating quality policy, metrics, and trends

Generate documents associated with technology transfer, implementation of new technology, and improvement of existing technologies, such as Device History records (DHR), batch records, evaluation protocols, summary reports and change control notices.

CROSSCOUNTRY HEALTHCARE- Florida 2004:

Software Validation Engineer- Perform IT Systems and Applications assessment for Corporate conformance with the Accounting Reform and Investor Protection Act of 2002 (Sarbanes-Oxley Act, aka SOX) including : GAP analysis, compliance auditing and remediation of internal software and financial systems testing (per JCAHO standards/ regulations)

WYETH pharmaceuticals Pearl River, New York 2004:

Validation Engineer- Write and execute media prep SKID Process Validation and Development Studies for Pharmaceutical solutions and intermediate components production. Team Lead for new- building Cleaning validation and environmental qualifications: coordinating the efforts and schedules of quality assurance, quality control, manufacturing, research and development, and validation personnel to properly validate the cleaning procedures associated with the expanded manufacturing suite.

Assign and monitor the work of the cleaning and process validation team members to ensure achievement of the Cleaning, Packaging and Process Validation Master Plans.

Review / approval signatory for written cleaning validation protocols and summaries.

Discuss engineering studies and validation plans with client and regulatory agencies as required during reviews & inspections.

ELI LILLY pharmaceuticals- Indianapolis Indiana 2003 to 2004:

Compile and execute equipment and systems commissioning and validation protocols (IQ/ OQ) for Parenteral Pharmaceutical manufacturing facility scale up and new construction. Including -27 Air handling units, 3- chemical fume hoods and 4- HVAC utility systems.

OWENS ILLINOIS medical devices- Indianapolis Indiana 2003:

Write retrospective facility validation (IOQ) for utility systems (HVAC) supporting Medical Device manufacturing facility, Building Automation System (BAS) and Injection Molding machine. Test via computer software qualification (CSQ) and perform 21 CFR part 11 compliance Assessments / software.

TYCO medical devices- Deland Florida 2003:

GAP analysis of current Standard Operating Procedures (SOPs) and Validations associated with facility Injection Molding machines. Generate and report Cost analysis / Risk analysis

PHARMACIA pharmaceuticals- Barcelonetta and Arecibo, Puerto Rico 2002 / 2003-

Write and execute validations (IQ, OQ, traceability matrix and final reports) -

Utilities: pharmaceutical grade water lines (WFI) mechanical commissioning.

Computer systems: omputer Control System qualification per 21 CFR part 11 including FAT/ SAT, Software validation, standard operating procedures (SOPs), deviations,.

CAPA closure and final reports. Equipment: pharmaceutical production equipment (Conveyor system, packaging line, reactor/ batch mix tanks) and the associated process control systems (Allen-Bradley & Siemens PLC's).

GENSIASICOR Biologics- irvine, California

Perform validations of pharmaceutical manufacturing equipment including parts washers, sterilizers/ autoclaves (EO &steam), WFI system and Mixing tanks.

Maintain the development, processing, cleaning and packaging protocols, raw data and summaries in an orderly manner’

Write Standard Operating Procedures (SOPs) relating to process / equipment

SENIOR QUALITY CONTROL SCIENTIST (NABI - Boca Raton, Florida 2000 to 2002):

Participate in laboratory workflow & personnel organization, prioritize and delegate responsibilities accordingly, documentation review, internal auditing, Validations (Manufacturing equipment & process/ method validations), Water testing, LAL (endotoxin testing), Microbial limits testing, organism ID, Environmental monitoring, equipment calibration. Negotiate vendor / supplier contracts, audits, & negotiations.

Perform cleaning validations associated with scale-up lots of drug product.

Prepares and/or reviews written development protocols for process control that assures that products have the identity, strength, quality and purity that they purport.

Prepares and/or reviews written cleaning validation protocols that assures that equipment has been cleaned to meet pre-determined acceptance criteria for residual active, detergent and surfactants.

Participate in supplier qualification activities

SENIOR MICROBIOLOGIST/ LABORATORY MANAGER (BW MEDICAL- ReProMed Division, Miami Florida 2000)

Coordinate laboratory Quality Assurance/ Quality Control activities in support of the manufacture, sterilization reuse of 'single-use' medical devices.

Develop and coordinate Laboratory and facilities equipment and Process Validations (IQ/ OQ/ PQ). Supervise/ manage laboratory work flow & personnel (5-direct reports).

QA COORDINATOR/ LABORATORY DIRECTOR (ANDERSEN Medical PRODUCTS,

Haw River, NC 1998- 2000)

Manage laboratory workflow and personnel, Training and delegation of responsibilities. Perform Quality management and assurance functions. Internal and external (vendor) audits for (ISO, FDA, EPA, GMP, GLP, GHP). compliance & suitability to Medical Device Manufacturing application.

Develop and maintain international regulatory submissions for CE marking,

Participate in a wide variety of device development teams from a regulatory perspective, including design control, risk management, and design and process validation

Review document change requests including assessments of regulatory impact

Cost/ Inventory/ Budget analysis, at a profit/loss responsibility level

MICROBIOLOGIST- SITE SUPPORT SCIENCES 1996 to 1998: CIBAVISION, Duluth Georgia

Environmental monitoring (air and surface monitoring), USP PW water/ solutions & Coliform testing, Bioburden & Spore titer Determination, Biological indicator use and validation. Equipment calibration, qualification, procedural (SOP) documentation and conformity surveillance. Trending and analysis of laboratory testing and Cleanroom environmental monitoring.

REFERENCES:

Lindsay Marine (Zimmer biomet, Warsaw IN- manager): 317-***-****

TJ Stowe (Pfizer, McPherson KS- project manager): 303-***-****

Sandra Boyd (Nanotherapeutics, Gainesville FL- quality director): 949-***-****

Dan Burkholder (Medtronic, Memphis TN- project director): 727-***-****

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