Clarissa Allen - Tampa Bay Area

Clarissa M. Allen449 28th AVE N, St. Petersburg, FL 33704E-mail: [email protected] Cell Phone: 727-200-7666

EDUCATION: JOHN JAY COLLEGE OF CRIMINAL JUSTICE, New York, NY

o B.S. Forensic Science – Forensic Criminalistics Investigation – May 2003

CERTIFICATIONS/TRAINING: CERTIFIED QUALITY AUDITOR – American Society of Quality (Clarissa Allen) (ASQ # 46326) – Dec 2013 CERTIFIED QUALITY AUDITOR – American Society of Quality (Clarissa Ramirez) (ASQ #40840) – June 2010 Lead Auditor for ISO 13485:2003 (Cert # LRT-10-105546) – September 2008 CERTIFIED SIX SIGMA GREEN BELT (ASQ #1157) – December 2007 EU, Canada, Japan Regulatory Process Review & EN ISO 13485:2012/RDC 16/MO.169/QSRs Comparison (16 Hour

Course) - August 26-27, 2013 AAMI 21CFR820 QSR Medical Device Course - August 2012

EXPERIENCE:

CRYO-CELL INTERNATIONAL, INC., Oldsmar, FL (April 2015 – November 2015)

Quality Specialist

Maintain Deviations, CAPAs, CARs, Change Control, and other quality system activities. Provides feedback to the department on documentation of nonconformance reports. Maintain current certification/accreditation with regulatory authorities. Perform internal quality audits. Maintain audit schedule. Performs batch record reviews. Provide quality support for the supplier qualification process in conjunction with the applicable departments. Initiate, review and revise SOPs, WIs, and Forms to support quality system activities. Maintain and stay abreast of quality and regulatory industry updates and knowledge (laws, regulations, policies, standards). Provide support to prepare Quality presentation for the quarterly management review. Create reports based on quality metrics. Participate in External quality and regulatory audits including ISO, FACT, FDA, AABB and State of Florida. Cryo-Cell’s main product line is related to storing Umbilical Cord Blood and PrepaCyte-CB Storage Solution (Medical Device) used in the storage of the Cord Blood. Related Product Regulations & Standards Include 21CFR1271, 21CFR820, ISO13485, AABB, and FACT.

JOHNSON & JOHNSON VISION CARE (VISTAKON), Jacksonville, FL (August 2012 – January 2015)

Staff Compliance Specialist

Independently Plans, co-ordinates and conducts Internal Audits for Supply Chain (Manufacturing, Operations Support, Laboratories, Facilities, Supplier Quality, Supplier Auditing, Facilities, Etc.). Johnson & Johnson Vision Care Site in Jacksonville, FL is made up of approximately 3000 personnel running 24 hours 7 days per week. Co-ordinates and manages external regulatory audits in partnership with site QRC and Franchise Compliance. Leads sites in preparation for successful external regulatory audits, which includes preparation of the Supply Chain Departments through floor walkthroughs weekly and implementation of Inspection Readiness Programs. Provides Compliance oversight for internal and external audit deficiencies and related CAPA. Reports Weekly Metrics on Supply Chain Compliance Internal Audit Health to Upper Management. Works completely independently since overseeing management is oversees at Ireland Johnson & Johnson Vision Care Facility. During 2 years at Johnson & Johnson Vision Care, maintained Internal audit CAPA metrics in Green Status during all months. Metrics were prepared weekly and sent out to owners and management and presented at weekly meetings to ensure timely completion. Prepared Monthly and Quarterly Management Review Metrics for the site for Internal Audits and attended site meetings representing compliance. All products at the Jacksonville Facility were Medical Device, FDA Class II & III Contact Lenses (Steam Sterilized) governed by 21CFR820, and also by regulations in Europe, Japan, Brazil, & Canada. Role in External Audits was as a Scribe, Back Room Supply Chain Lead, and Subject Matter Expert Preparer. Trained two (2) Lead Internal Auditors from the Quality Engineering Department and Microbiology Laboratory.

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ORTHO CLINICAL DIAGNOSTICS (Johnson & Johnson), Raritan NJ (April 2011 – August 2012)

Staff Compliance Engineer

Functioned as part of a Supply Chain Compliance Team to plan, co-ordinate and conduct Internal Audits, External Audits, & Inspection Readiness Programs across multiple OCD sites. Personally Responsible for Compliance Program at three (3) Ortho-Clinical Diagnostics Sites, Veridex in Pennsylvania for Combination Pharma/Med-Device Product, Therakos which is Virtual Company (Completely Outsourced) for Combination Pharma/Med-Device Product, and several of the Blood based products at the Raritan Facility. Co-ordinates and manages external regulatory audits in partnership with site QRC. Leads sites in preparation for successful external regulatory audits, as well as Customer Audits. During External and Customer Audits, served as a Host, Scribe, & Back Room Lead. Provides Compliance oversight for internal and external audit deficiencies and related CAPA. Management Review was prepared for all three (3) companies on a quarterly basis and presented to the management of those companies. Represented Compliance as for escalated complaints being considered for Recalls as part of 21CFR806 process. Products at the various OCD sites were governed by 21CFR820, 21CFR 210 & 21CFR211 and 21CFR600 depending on the product. The products under 21CFR600 required special handling on both receipt of the blood, throughout the processing and the shipment post processing which all needed validation and close monitoring. I also completed 10 supplier audits on OCD’s behalf for my region (New Jersey and Pennsylvania) in 4Q2011 which included 2 animal facilities, several chemical facilities, a transporter, and two injection molding facilities. During the Supplier Audits trained two (2) Lead Internal Auditors for OCD, one for Compliance and one for the new Supplier Auditing Department.

LIFECELL CORPORATION, Branchburg NJ (August 2009 – March 2011)

Senior Quality Compliance Auditor (March 2010 – March 2011)

Supports LifeCell’s internal audit program ensuring an annual internal audit schedule is generated as required. Further supports this area ensuring audits are performed as required, and all follow up activities as required. Identifies internal compliance gaps/areas for improvement and ensures these gaps identified are prioritized based on risk.

Supports external inspections performed of LifeCell as needed, which included scribing and back room lead. This includes performing inspection readiness activities (trainings, walkthroughs in sterile core), ensuring adequate resources are available to support/host outside inspections, facilitating the inspections, working with the QA group to ensure Quality Investigations are initiated for inspection findings as applicable, ensuring that audit findings are appropriately addressed through corrective and/or preventive actions within agreed upon timeframes, and ensure inspection follow-up activity is coordinated/performed. Presents Inspection Readiness powerpoint presentations to all site staff in multiple shifts in cafeteria before every planned external audit. LifeCell’s main product line is terminally (Gamma) sterilized human and porcine tissue implants goverened by 21CFR820 & 21CFR1271

Senior Supplier Quality Engineer (August 2009 – March 2010)

Supports LifeCells Supplier Compliance Audit Program ensuring that all supplier audits are scheduled and completed in a timely fashion by working with the Senior Supplier Auditor. Ensure that all SCAR’s generated from Supplier Audits are followed up on in a timely manner and closed with appropriate corrective actions. Manage any arising supplier issues that come up within the plant directly with the supplier to ensure that product supply is uninterrupted. Work closely with incoming QC inspection as well as distribution to ensure all supplier issues are managed quickly and appropriately within a SCAR. Track and Trend SCAR’s and report to management on a Monthly and Quarterly basis. Performed Supplier Audits as needed by Senior Supplier Auditor.

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SIEMENS HEALTHCARE DIAGNOSTICS, Tarrytown NY (August 2008 – August 2009)

Internal Audit Manager - Quality Engineer III (Quality Systems & Compliance Department)

Managed the Internal Audit Program for the Tarrytown, NY Site, which included managing approximately 20 Internal Auditors from the Regulatory/Compliance Department that completed 1-2 internal audits each per year. Implemented Risk Based Internal Audit Program to site in March 2009. Participate in Global Internal Audit Team focused on harmonizing Internal Audit Programs Across Siemens Healthcare Diagnostics. Ensure compliance with ISO 13485, ISO 9001, FDA, IVDD, and CMDCAS Requirements. Leads site preparation for External Inspections at Tarrytown, NY and Flanders, NJ sites. During External Audits, served as host, scribe or back room lead depending on the needs of the audit. Manages Corrective and Preventive Action (CAPA) resulting from nonconformities found during audits (Internal/External).

Manage Post-Market activities for In-Vitro Diagnostic Products. This includes MDR’s, Recalls, Field Corrections, and Investigations at the Tarrytown and Flanders sites as per 21CFR803 & 21CFR806 Requirements. Department Representative handling inquiries from Ex-US Regulatory Authorities on Field Corrections and Medical Device Reporting for several countries such as Ireland, UK, France, Germany, Australia, Japan and others as needed.

MANNKIND CORPORATION, Danbury CT (June 2005 – July 2008)

Quality Assurance Specialist II (April 2008 – July 2008)

Represent QA in performing Criticality Assessments of instruments in both the laboratory and manufacturing areas. Address instrument calibration failures and resulting product impact. Project Lead on the creation of a document control center for commercial facility. Audit other departments’ current systems of PAI critical documents. Creation & maintenance of databases to support document control center. Management of two College Interns participating in creation of document control center. Disposition of Raw Materials & Components for QA approval.

Technical Assessments Specialist II, Data Analyst [Note: Quality Engineering Department] (February 2007 – April 2008)

Represent QA in performing Criticality Assessments of instruments in both the laboratory and manufacturing areas. Address instrument calibration failures and resulting product impact. Project Lead on the creation of a document control center for commercial facility. Audit other departments’ current systems of PAI critical documents. Creation & maintenance of databases to support document control center. Management of two College Interns participating in creation of document control center. Disposition of Raw Materials & Components for QA approval.

Method Development & Validation Associate (March 2006 – February 2007)

Working with engineering, regulatory, research and development, device development, and clinical manufacturing providing professional guidance to assess, correct, and maintain the product and process quality using statistical tools, documented methods, experimental designs, and sampling plans. Provide technical advice to the site leadership team on quality, reliability, safety and performance issues encountered during product life cycle. Responsible for:

Manage data entry and statistical analysis during product development, stability and clinical manufacturing phases

Analyze, Interpret and summarize quality control, stability and clinical manufacturing data for senior scientists, engineers

Perform protocol lot reviews, analyzing data to assess trends Use statistical tools and techniques to assess and improve data quality Conducting Laboratory work to support investigations Participate in Method Validations when required Create and Maintain data tables for all company non-clinical stability testing used in governmental filings Review of non-clinical data for technical content prior to QA disposition.

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QC Finished Products Associate (June 2005 – March 2006)

Dry Powder Inhaler Dosage Form Pharmaceutical testing, start-up pharmaceutical/medical device company working towards FDA Approval of First Brand Product. Responsible for testing of all stages (raw material thru finished product) of drug using Anderson Cascade Impactor, Delivered Dose Apparatus, Assay (HPLC), Content Uniformity (HPLC), and Residual Solvents (GC). SOP Revision and TM Revision.

WATSON LABORATORIES INC., Danbury, CT & Carmel, NY (June 2003 – June 2005)A SUBSIDIARY OF WATSON PHARMACEUTICALS INC.

Analytical Research & Development- Scientist 1

FDA cGMP compliance regulated laboratory. Generic Pharmaceutical Solid Dosage Form Testing from product development through ANDA submission, including all E-Batch, stability testing, raw material, method development & method validation testing. HPLC analysis for ICH Impurities, Assay, Content Uniformity, & Dissolution. Dissolution Testing by UV/Vis, both Automated and Manual. Extensive Method Validation, testing and reporting. GC testing for Residual Solvents. Method Transfer and Cleaning Validation experience. In 2 years work on approximately 25 developmental generic pharmaceutical projects. Participated in 5 ANDA filings and FDA inspections for the generic drugs.

CIBA SPECIALTY CHEMICALS CORP., Tarrytown, NY (June 1998 – Feb. 2002)

Research & Development Department: - Co-Op Student (June 2001 – February 2002)Prepared, purified and characterized 18 novel ultraviolet absorber research compounds used for the stability of clear plastic. Evaluation of the photostability of research compounds. Determined the effect of various ink-jet systems on the stability of ink-jet dyes. Inventory of Chemicals.

Lubricant Additives Department: - Co-Op Student (June 1998 – June 2001)Worked on Automotive Oil R&D projects involving different additives developed by Ciba Specialty Chemicals utilizing ASTM testing standards. Responsible for bi-annual calibration of oxygen flow meters, weekly titration of degrading oil samples, Viscosity testing of oils, FTIR Library of company additives, RULER Library of oils and company additives, Inventory of Chemicals and Oils. Part of the R&D team which helped develop the oil formulation for Mobile 1 oil.

LABORATORY TRAINING:Fundamentals of Empower (Certification) – Waters Training Specialist, 2005Advanced HPLC for Pharmaceutical Analysis – Pittcon 2005Basic HPLC Method Development – Pittcon 2005GC Fundamentals, Applications & Troubleshooting – Pittcon 2005How to Validate a Chromatographic Method, a Practical Course – Pittcon 2005JMP Software: Statistical Data Exploration – 2006

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