Project Manager Management

Adriane E. Evans

*** ******* ***** – Bear, DE ***01

Cell 301-***-**** Email: ab04jb@r.postjobfree.com

Executive Profile

A highly motivated Lead Quality Administrator with professional experience in the biopharmaceutical

(13485 - medical device and 9001:2008 – Quality Management System [QMS]) standards and healthcare.

Risk assessments performed (14971, NIST and best practice guidelines). Strong management, problem-

solving and supervisory skills. An experienced certified quality trainer and lead auditor. Primary

focus developing/implementing a QMS program, continuous improvement and writing policy

and procedures for organizations and developing programs/departments.

Summary of Qualifications

• Lead auditor, with management of the internal audit program (10 – 15 internal auditors)

• Project Manager: special projects

• Develop and implement organization Quality Management System (QMS)

• Knowledge of 13485 standard, familiar with 510k, cGMP and GMP (Medical Device

Classifications I, II III and 483 Warning Letters)

• Developed, monitored and update CAPA database, (verify/validate actions as appropriate)

• Participated in TJC and FDA regulatory inspections

• Finance: Develop revenue generating streams, budget (track, trend, forecast, and

collections

• Program Development: Develop departments/programs, write and implement policies and

procedures

• Supervisory skills: Supervise staff of 6 - 10 employees’ w/cross functional abilities.

Obtain additional staffing as needed; perform evaluations, and work development plans

• Procurement and contract negotiations

• Computer skills include Word, Excel, PowerPoint, Outlook, Visio, Adobe Acrobat 9, and

Publisher

Education and Training

MS- 05/05 University of Maryland University College (Master’s Program)

Major: Management - Minor: Healthcare Administration

BS- 05/99 University of Maryland University College (Baccalaureate Program)

Major: Management - Minor: Healthcare Administration

Training and Certifications

American Society of Quality – Certified Quality Auditor (CQA)

Certified RABQSA Lead Auditor – ISO 9001:2008 (114768)

Certified IRCA Auditor – ISO 9001:2008 (600895)

Certificate 13485 Medical Device

Project Management Training 2007/Project Management Fundamentals 2011

Certificate Medical Terminology

Adriane E. Evans (Page 2 of 3)

Professional Working Experience

7/2012- Present

QAI, 7830 Johnson Road, Indianapolis, IN 46250

Title: Certified Instructor - ISO 9001: 2008

Provide instruction and training in the Quality Management System and the ISO 9001:2008

Standard.

02/2005 – 9/28/2012

American Nurses Association, 8515 Georgia Ave, Silver Spring, MD

Title: Quality Management Specialists/Program and Training Development Specialist/

Lead auditor with management oversight of the Quality Management internal auditor team (10-15

auditors). Assesses relevancy of audit findings, potential exposures/risks, materiality, improving

or deteriorating trends, and integrates "big picture" issues into analysis. Identifies additional risks

not previously considered and understands secondary or tertiary issues. Responsible for planning,

conducting and reporting on internal, external and management audits. Develop audit scope by

determining the audit objectives; procedures; and internal control review required to ensure

company policies and procedures are in effect and working as intended. Establish and develop

work standards and procedures for staff to include training. Develop recommendations for

corrective measures to rectify audit observations. Responsible for maintaining and updating all

corrective/preventive actions (CAPA’s) and verifying and validate for effectiveness. Writes and

reviews audit reports to ensure they are objective; accurate; and properly document and support

audit findings. Communicates audit findings and recommendations to executive leadership and

management staff. Recommends policy and procedure revisions to senior management to ensure

compliance. Respond to executive and senior management queries on internal controls and audit

findings. Stays abreast of changes to processes and federal and statutory regulations. Provides

input into the development of the department budget. Recruit; train, develop; and motivate

internal auditors. Provide feedback and coaching to audit staff. Experience working with

consultants and 3rd party auditors, adding value and pursuing professional contacts to strengthen

and expand the Quality Management Systems (QMS) Program. Develop and conduct auditor

surveys using evaluation tools. Prepare, write and develop the Quality Manual to include the

Quality In Action Update Newsletter (QIA) Newsletter – quarterly and the ANCC Employee

Hand Guide. Understands business priorities, and anticipates issues and obstacles, incorporating

these concepts into risk discussions. Effectively compiles relevant, material findings and

recommendations into readable and concise audit reports. Communicates complex results and

implications, incorporates different perspectives into deliverables. Effectively communicates

audit process, scope, protocol, issues, risks and recommendations to auditee during kick-off,

periodic status updates, and exit meetings.

Adriane E. Evans (Page 3 of 3)

4/2001 – 7/2003

Georgetown University Hospital, 3800 Reservoir Road, Washington DC.

Title: Administrator for Operating Room (OR)

Developed budget ($23 million dollars), monitored expenditures for the fiscal year. Forecast

budget, reviewed and analyzed financial reports. Manage administrative staff, direct and

authorize payroll processing ($12 million dollar). Performed cost benefits analysis. Work with

physicians, sales representatives, and designers in developing medical devices (pre-market

surveys; FDA filings – 510K; managed and negotiated agency contracts. Direct responsibility for

procuring medical equipment and office furniture. Ensured contract and pricing compliance.

Function as a resource for staff and management on all personnel, educational and human

resource issues. Worked collaboratively with nurse management to ensure the success of the

expansions of the Operating Room, Post- Acute Care Unit and the Sub-PACU units. Participate

and prepare staff for Joint Commission on the Accreditation of Healthcare Organizations JCAHO

audits. Performed personnel management functions not limited to: interviewing, hiring,

terminating and orienting employees. Designed and developed Surgery Center brochure.

Developed and wrote policy and procedures. Collaborate and direct the management of reports

with OR Systems Coordinator. Participates in department wide operational/strategic planning,

marketing activities and special projects and is accountable for implementation in areas of

responsibility.

1992 – 1998

BioReliance - 9630 Medical Center Drive, Rockville, Maryland, 20850.

Title: Sr. Administrative Specialists

Provide senior-level administrative support to the Director. Managed the everyday functions of

the office. Wrote and implemented administrative office policies and procedures. Familiarity

with GLP, cGMP, and clinical trials (In-Vivo, In-Vitro, MAP and other assays). Excellent

problem solving skills. Database Administrator, and point person on software issues/training.

Coordinated and managed the work of the administrative staff. Monitored and responsible for all

study reporting. Maintained successful relationships with clients. Solid project management

skills. Division timekeeper. Monitor telephone, office supplies, and messenger services and

subscriptions expenses. Petty cash custodian. Strong proofreading and organizational skills.

Procured office supplies and equipment. Member of the Communication Design Committee.

Member of the Training Focus Group.

1983 – 1987

Downstate Medical Center, Brooklyn, New York

Title: Office Manager

Work with Amgen in clinical trial development for Erythropoietin (EPO) study. Responsible for

clinical trial development (processes, policies and procedures, process all patient

stipends/reimbursements; track clinical trial paperwork; perform data entry and downloads on

patient results (adverse reactions, other events as appropriate; recruit new patients, arrange for

patient transportation); coordinate all meetings with stakeholders to ensure timelines are met;

responsible for project budget; transcriptionist, scheduled appointments; flight arrangement

(overseas/complicated); procure office furniture; typed medical reports; developed conferences

for 200 people.

Professional Consulting Experience

Healthcare Systems Research - Personal Assistant to President: 2\2000 – 7/2000

Thomas Jefferson Hospital - Project Manager: 10/2006 – 7/2007

Volunteer Experience

6/2012-Present

American Society of Quality, 600 N. Plankinton Avenue, Milwaukee, WI 53201

Title: Reviewer

Contribute to the development of the American Society of Quality's (ASQ's) inaugural Quality

Book of Knowledge for Healthcare. Collaborate with stakeholders in the development of this

effort. Analyze proposed input for inclusion in the Quality BOK. Amends industry vetted

quality and healthcare subject matter and eliminates irrelevant text proposed for inclusion in the

document.

Contact this candidate