Quality Assurance Management

R oxane Y. McMorris

P.O. Box **** ~ Washington DC 20013

******.********@*****.*** C: 773-***-****

PROFESSIONAL PROFILE

Executive-Level Presentations & Negotiations ~ Operations/Internal Process Management

Strategic Planning ~ Project Management ~ Relationship Building & Management

Accomplished quality professional with a thirteen year record of success developing and implementing GxP compliance, and

leadership to improve overall quality operating efficiencies for start-ups and multi-national organizations.(R&D,

Pharmaceuticals/Vaccines, Clinical Trials, Manufacturing, Quality Management Systems, Audits, Laboratory Systems and

Training). Detail-oriented, compliance professional with extensive internal and external laboratory audit background.

Performed validations of analytical methods and computerized systems. Designed protocols to investigate complex and

problematic issues with diagnostic assay components using statistical analysis of data. Recognized for effective writing,

presentation and management skills. Visionary leader with experience collaborating with all levels of an organization to effect

positive change. Quick study with the ability to adapt to new and competing priorities.

OXFORD INTERNATIONAL (For McNeil – JNJ)

Quality Assurance Specialist (Contractor) April 2013 - Present

Ensure compliance to domestic and international regulations and guidelines. Manage department Trackwise Problem Records through

the initiation, review, release, closure and trending of OOS, deviations, customer complaints, investigations and CAPA’s.

• Serve as a liaison between McNeil site Quality and the Central Quality organization.

• Evaluate systems for improvements and risks, develop, and implement improvement plans.

• Ensure organization and quality system compliance with all applicable local regulations and J&J standards.

• Monitor, train and coach CAPA owners and functional process users about Key Performance Indicators and identify opportunities

for continuous improvement.

• Perform Lead Investigator role to ensure effective event management/CAPA projects.

• Investigates all exceptions, pre-approve all processing for corrections of non conformities and assure appropriate CAPA plans.

• Lead on-going continuing efforts to improve Quality Systems (In-Process Reporting, etc.).

• Interface with other departments to coordinate the development of regulatory and quality procedures and quality documents and

controls to ensure compliance in a timely manner.

• Analyze impact of failure within and across product lines.

• Review and disposition document changes.

• Ensure timely and consistent escalation of events

• Provide feedback to Operations on problems related to Quality & Regulatory Compliance.

LONZA

Quality Assurance Specialist IV January 2012 – April 2013

Responsible for establishing, implementing and maintaining a compliant Quality System while responsibly achieving cost expectations.

Used statements of work. Strong knowledge of regulations and standards affecting IVD’s and Biologics in the US and EU. Managed

process development, downstream processing, technology transfer, assay qualification, assay validation, development of tangential flow

filtration as a method of downstream processing. Assured consistently high quality clinical trial products, and collaboration with QP

colleagues.

• Ensured compliance to domestic and international regulations and guidelines.

• Ensured timely disposition of materials and product with compliance to written procedural requirements.

• Investigates all exceptions, pre-approve all processing for corrections of non conformities and assure appropriate CAPA plans.

• Represented Quality for FDA inspections and client audits, audit responses, new policies or changes.

• Used technical dept in process and test methods to assist in preventive actions.

• Analyzed impact of failure within and across product lines.

• Advanced understanding of process and test method validation. Able to relate information to specifications, clinical utility,

product claims and design.

• Understands the impact of testing and process variation on manufacturability and field performance.

• Proficient at risk management.

• Processed SOP documents, investigations, CAPAs and change control documents using SharePoint, Access, Word and Excel.

• Reviewed /Approved / Rejected equipment qualifications, process validations, computer validations, protocols and reports.

• Reviewed /Approved / Rejected completed manufacturing batch records for final product release.

• Established metrics and targets for quality; develop the associated continuous improvement plans.

Roxane Y. McMorris Page two

PROFESSIONAL EXPERIENCE

(Continued)

• Provided feedback to stakeholders.

• Hosted and managed external CMO client and supplier audits.

TACONIC September 2010 – January 2012

Sr. Quality Assurance Administrator

Responsible for the creation, adaptation, implementation and administration of the Taconic quality system, using ISO 9001, 17025, ISO

8402:1994, GLP and GMP requirements. Audited study procedures to assure management that the facilities, equipment, personnel,

methods, practices and data/reports were in compliance with applicable regulations and/or standard operating procedures as required by

site.

• Final review and approval of quality – related document, including protocols, qualification, validation and stability reports, test

results, raw data, calibration certificates, temperature charts.

• Reviewed executed cell therapy manufacturing batch records for compliance of manufacturing processes/steps, ensuring that all

applicable documents, records and forms are complete and accurate.

• Developed controlled documents and procedures pertinent to Quality Assurance activities and functions.

• Conducted GMP and GLP audits (internal and external) for Taconic departments, vendors and suppliers.

• Created, issued, tracked, reviewed and approved control of labeling of materials and equipment.

• Monitored and verified the qualification and validation processes to ensure compliance to written protocols, and regulatory

requirements.

• Conducted Quality Assurance training.

• Participated in cross-functional team projects and initiatives.

• Maintained a comprehensive quality program, including raw material specification, non-conformance and corrective action,

equipment control, computer validation (VV&T), standard operating procedures and training.

• Planned, implemented and managed internal audit program.

• Hosted and managed external audits.

LOGISTICS HEALTH INCORPORATED August 2008 – September 2010

Per Diem Consultant

Designed, implemented, and managed quality systems to provide innovative quality solutions to support the Department of Defense and

the Department of Health and Human Services in the delivery and management of medical readiness, occupational health and wellness

services.

AERAS GLOBAL TB VACCINE FOUNDATION February 2008 – August 2008

Quality Assurance Specialist

Performed an effective gap analysis to establish necessary change to develop and implement successful programs and systems: Quality

Management Systems, Document Control, Change Control, Investigation/CAPAplan, Lot Release, Training, and Auditing.

• Advised the CEO and Department Heads of communications regarding federal regulations and compliance issues.

• Demonstrated ability to develop and manage quality systems and complex issues.

• Conducted internal and external GMP, GLP or GCP audits as applicable, generated reports and tracked corrective actions, ensuing

these key deliverables accurately reflected the collaborative effort of 21 CFR regulations and guidance’s.

• Supported QA system installation at clinical sites.

• Reviewed executed manufacturing batch records.

• Reviewed QC EM data for compliance with AERAS and regulatory requirements.

• Conducted supplier audits for critical materials and services.

• Supported CMO activities through material qualification and SCAR activities.

• Monitored deviations Sop development and implementation.

• Monitored Out of Trends and Out of Specification investigations.

• Prepared monthly trending and ad hoc reports for various QA investigative systems.

• Assisted other business units with SOP development, training and implementation.

CYLEX INCORPORATED

Senior Quality Assurance Specialist July 2005 – February 2008

Performed Head of Quality responsibility for two years, implementing QSR ISO and FDA regulations.

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PROFESSIONAL EXPERIENCE

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• Analyzed data and information related to product performance characteristics and other business metrics.

• Identified and evaluated options, and implemented additional actions and alternatives based on business needs and clinical

relevance.

• Performed On-the-Floor QA reviews and inspections.

• Performed QA facility release activities.

• Reviewed In-process and Final release test results.

• Performed batch record reviews, responsible for lot release of components of kits and raw materials.

• Responsible for compliance activities (ie CAPAs) and all GMP training.

• Responsible for issuing, tracking and controlling protocols, validations, SOP’s, using SharePoint, Access and Excel documentation

formats.

• Recommended and implemented innovative ways to improve performance characteristics and business metrics on an ongoing basis.

• Aligned improvements with internal and external customer expectations.

• Planned, implemented and managed internal audit program.

• Hosted and managed external audits.

ALPHARMA January 2004 – July 2005

Quality Auditor

• In depth knowledge of cGMP in the pharmaceutical industry.

• Audited records to ensure compliance with 21 CFR Part 11. Subpart F Production and Process Control.

• Evaluated quality impact of process deviations.

• Reviewed and approved release status of batches to packages.

• Identified the need for investigations for deviations, provided follow-up when necessary.

• Provided training for batch record auditing, QA records, i.e. Log books, holds notices as required by established quality systems.

ABBOTT LABORATORIES July 2000 – July 2003

GMP Coordinator

• Coordinator for cGMP, Safety and ECF. Also proficient in IMx testing and design/troubleshooting of the HBe assay.

• Performed numerous extensive audits implementing 21 CFR Parts 210 and 211, ISO 9001 and 13485, and the ADD Quality Policy.

• Ensured the components of the Hepatitis B Virus (HBe) diagnostic kit performed optimally.

• Conducted investigative studies and devised plans to troubleshoot EIA and IMx failures.

• Responsible for observations, corrections, responses and CAPA documentation for all internal and FDA lab/documentation audits,

provided necessary feedback to stakeholders..

• Audited monthly instrument maintenance logs to assure ongoing internal and FDA compliance.

• Coordinated and scheduled cGMP duties for self and team of 20. Worked with team of 6 other coordinators to ensure divisional

lab/instrument and safety compliance.

• Selected as Safety Officer and implemented safety procedures on an on-going basis, including safer equipment, lab and disposal of

chemicals for a level II/III biohazardous, po-biohazardous and radiation labs.

• Certified, developed, validated, manufactured and tested biological products for the HBe Test Kit Pac.

• Hosted department internal audits by Site Quality.

E D U C AT I O N

GOVERNORS STATE UNIVERSITY, University Park, IL

FLORIDA MEMORIAL COLLEGE, Miami, FL

PROFESSIONAL TRAINING

~ASQ Implementing and Auditing an ISO 9001 Quality Management Systems May 2005

~ UMBC Regulatory Issues in Biotechnology August - December 2007

~ UMBC GMP for Bioprocesses January – May 2008

~ THE CENTER for Professional Advancement Conducting Effective Quality Audits May 2008

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