SHEILA JONES

ADDRESS: **** *. ***** **** #*** BOYNTON BEACH, FLORIDA 33435

PHONE/ TEXT: (561) 703- 1753

EMAIL: ac7b3y@r.postjobfree.com

PROFESSIONAL OVERVIEW:

Currently serving as a Quality Assurance/ Compliance- Technical Consultant to pharmaceutical and medical device manufacturers; developing Quality Systems documentation and performing project engineer functions supporting the validation of cGMP manufacturing processes, equipment, testing, cleaning and methods development. Scientific education and Technical skills acquired via "Hands On" manufacturing and testing experience from the ground up (process engineering, equipment/ software validation, & testing methods development, execution, and documentation) from laboratory testing through regulatory submissions, vendor/ supplier conformance audits, GAP analysis and remediation (CAPA) corrective/ preventive actions.

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

Supporting cGMP quality systems for FDA regulated Medical device and Pharmaceutical manufacturers. ISO 13485, GAMP5, ISO 14644, ISO 9001, 21CFR part 11 (210/ 211) and 21 CFR 820 Compliance via QSR documentation package formation, procedural (SOP )development, review, auditing. Performing internal reviews, external vendor/ supplier oversite of corporate FDA, EU and ISO regulatory audits.

* 8 years experience in Manufacturing Equipment 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, PFMEA, GAP analysis 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 and reporting critical project activities (testing) and deliverables(reports). Fluidly realigning responsibilities and objectives in response to project developments and routine manufacturing/ production demands in support of project timelines.

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

Write, develope and review process/ system supporting documentation packages 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), LIMS systems, TrackWise, Documentum, LotusNotes, and Sharepoint applications in support of Lean Manufacturing and SixSigma methodologies

EDUCATION:

UNIVERSITY OF GEORGIA, Athens GA:

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

Degree: Bachelors of Science, Microbiology

QUALITY ASSURANCE / PROJECT DOCUMENTATION EXPERIENCE:

Change control/ management supporting systems, site,& equipment Corrective Actions/ Preventive Actions (CAPA)

Quality System requirements & Standard Operating Procedures (SOP) development

Training suites development and initiation

CleanRoom & Manufacturing facility and utility systems construction/ commissioning

Computer System/ Software Acceptance Testing (SAT/ FAT)

ISO,GMP,CE mark & FDA regulatory submissions/ audit responses

Design control documentation, PFMEA, Risk Assessments and Engineering Studies

Validation plans and Traceability matrices:

Installation Qualifications (IQ)

Operational Qualifications (OQ)

Process/ Performance Qualifications (PQ)

Automated Control Systems, including Building Management Systems (BMS)& LIMS validation

MANUFACTURING EQUIPMENT / PROJECT ENGINEERING EXPERIENCE:

Sterilization Systems (gamma, gas and steam)

Industrial HVAC systems

Air Handling Units (AHU) & fume/ chemical hoods

Sterile Air Handlers

HEPA air filtration systems

Computer Systems

Conveyor lines (Bosch)

Heat sealers

Cozzoli machines

Mix tanks/ Reactors/ Filters

Water (WFI and RO filtration) systems

Air handling systems

Packaging systems

DCS & PLC Control Systems

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

Autoclaves (EO gamma &steam) temperature mapping (KAYE and wireless dataloggers)

PREVIOUS CLIENTS:

GensiaSicor

Allergan

Pharmacia/ Pfizer

Medtronic

Novartis(CibaVision/ Alcon)

TYCO

Glaxo-SmithKline

Eli Lilly

CREDENTIALS/ CERTIFICA TIONS:

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

* ASTM Certification- ISO (International Standards Organization) 9001 Internal Auditor

* PADI Certification- Advanced Scuba Diver & Environmental Underwater Naturalist

* CDC (Centers for Disease Control) Certification- Primary Epidemiology

* AAMI (Association for the Advancement of Medical Instrumentation) Certification- QSM (Quality Systems Management ) Quality System Requirements (QSR)

WORK EXPERIENCE:

QUALITY ASSURANCE AND COMPLIANCE CONSULTANT (VIA JACOBS ENGINEERING)

Pfizer- McPherson, Kansas December 2017- october 2018:

Sterilization & CAPA Remediation Project Lead- Direct oversite of 13 personnel.

Perform CAPA related process audits in response to regulatory compliance infractions (Root cause analysis and system Risk assessments). Define remediation plan. Perform testing and subsequent change control in accordance with ISO, FDA, Eu and cGMP requirements.

Nanotherapeutics- Gainesville FL January 2016- November 2017:

Quality Assurance/ Project Manager- Coordinating the New (Dept. of Defense) contract laboratory/ facility Construction/Commissioning and systems validation support. 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), Opthalmic devices Atlanta, GA September 2014- December 2015:

Develop and implement a detailed audit plan streamlining the consolidation of redundant corporate SOPs, manage/ coordinate the internal auditing functions, initiate procedural modifications, manage and track through Change Review and develop training programs.

AMBU, Medical Devices Indianapolis, IN February- August 2014 :

Validations Engineer- 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. Project Team of 24 personnel.

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

Validations Engineer- Medical Device reprocessing. Coordinate project team of 16 personnel in Cleaning Method development including Outsourced Sterilization vendor selection and quality standards 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)- Coordinate the selection and 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 remedial efforts 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 product manufacturing suite including building management system (BMS) upgrades, COTS software validation, equipment validation, excursions justification and initiation of Corrective / Preventive actions.

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

Quality Assurance- FDA 483 remediation (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 to device impact on sterility assurance and cleaning efficacy.

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

Project Manager- for corporate scale up/ facility transition to ISO9001 certification. Provide guidance on new FDA regulated products including: documentation review/ GAP analysis, submit procedural change controls and recommend additional test protocols. Institute company wide transition to electronic records maintenance and approval methodologies. Liason between governing regulatory expectations (FDA) and Clients (medical device producers) application /enforcement; represent as their Quality Ambassador during regulatory agency audits (ie: FDA and ISO) supporting communications, interactions, submissions and audit responses.

BIOTEST- pharmaceuticals- Boca Raton, FL 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 (ISPE) workshops, Provided training to Manufacturing and QA personnel on quality documentation of testing results pursuant to Good Manufacturing Practices (cGMP) and FDA guidelines.

SCIENTIFIC QUALITY CONSULTANT & VALIDATIONS PROJECT MANAGER:

2002-2006 (via TRACEMATRIX Technical staffing co.) Boca Raton, Florida.

Communicate openly and often with cross-functional project staff to evaluate production process needs, resolve problems and obstacles, provide resources, reset direction and maximize effective interactions and functioning.

Assign accountabilities, develop and monitor individual objectives for each subordinate to including performance plans and conduct performance management reviews, Staff evaluation and compensation reviews for employees.

Coordinate, review and monitor training initiatives for multiple project teams with a focus on timelines and scheduling.

Generate and/ or review process validation protocols/ test methods, and establish product specifications and acceptance criteria.

TRACEMATRIX Client- 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.

Develop process oriented documentation (SOPs, Engineering Design Studies, equipment qualifications and risk assessments and final product testing).

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.

TRACEMATRIX Client- CROSSCOUNTRY HEALTHCARE- Florida 2004:

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)

TRACEMATRIX Client- WYETH- vetrinary products- Pearl River, New York 2004:

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.

TRACEMATRIX Client- ELI LILLY pharmaceuticals- Indianapolis Indiana 2003 to 2004:

Compile and execute equipment and systems commissioningand 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.

TRACEMATRIX Client: 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.

TRACEMATRIX Client: TYCO, 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 associated with findings.

TRACEMATRIX Client: PHARMACIA- 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).

TRACEMATRIX Client: GENSIASICOR Biologics- rvine, 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- 1998- 2000: ANDERSEN Medical PRODUCTS,

Haw River, NC

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. Oversee institutionalization of safety / regulatory standards.

EPIDEMIOLOGY RESEARCH ASSISTANT- DEPT. of MEDICAL MICROBIOLOGY,

UNIVERSITY OF GEORGIA,,Athens Georgia 1995 to 1996

Water sanitization and chemical composition analysis. Analysis of Avian samples for epidimiological study of Campylobacter jejunum. Assist in data collection/ tabulation, and Media preparation and storage.

LABORATORY TECHNICIAN- CENTER for APPLIED ISOTOPE STUDIES,

UNIVERSITY OF GEORGIA,,Athens Georgia

Radio Carbon dating of organic and synthetically derived consumer products.

GENETICS LABORATORY ASSISTANT DEPT. of PLANT SCIENCES

UNIVERSITY OF GEORGIA,,Athens Georgia

Plant culture and embryo growth and maintenance, Sterility assurance, Genetic shooting of plant cultures, Immuno assay, Gel chromatography, Stock/ media preparation and maintenance, Quality Control.

RESEARCH ASSISTANT DEPT. of ECOLOGY, UNIVERSITY OF GEORGIA,,Athens Georgia (internship in El Yunque, Puerto Rico) 1994, Design, institute, and facilitate experiment concerning effect of crustaceans on sedimentation in fresh water rivers.

REFERENCES:

Cory Black, SynerQ technical staffing- CEO: 317-***-****

Scott Ridenour, Engineering Dept- FAU: 561-***-****

Daniel Burkholder, Medtronic Quality Control Supervisor: 727-***-****

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