SUMMARY:

I am an experienced professional with extensive knowledge in the hospital, biotechnology and pharmaceutical industries. I have a proven ability to deliver quality results with high attention to detail. I possess superior administrative skills with the ability to prioritize and accomplish deadlines under strict timelines. My most valuable asset is the skill at learning new concepts quickly as an individual and collaboratively as a team.

TECHNICAL SKILLS:

Technical report writing

Project Management

Computer Applications:

Oracle

CATSWEB

Microsoft Office Applications: Word, Excel, PowerPoint, Outlook

Intellivenge/Excellivenge for building MFG production daily schedule

LABORATORY AND ASEPTIC SKILLS:

Aseptic techniques under ISO5, ISO7, and ISO8 clean room environments

Centrifugation

Good Manufacturing Practices

Sample Extraction

EXPERIENCE:

Confidential, Union City, GA

Manufacturing Operations Coordinator

Responsibilities:

• Ensures schedule adherence and recommends alternatives to scheduling exceptions
• Provides direction to Manufacturing Operations associates as needed
• Monitors, audits, and resolves manufacturing operations issues on and off the floor
• Responsible for ensuring production documentation is accurate and in compliance with all regulations and procedures, knowledge of Documentation control principles
• Responsible for handling departmental documentation, investigations, impact assessments, and technical guidance
• Act as subject matter expert(SME) for revisions or improvements to the Provenge manufacturing processes
• Mentor Manufacturing Associates and train new hires on manufacturing processes
• Perform operator and verifier roles on clinical study trials/ Assisted with DN24 - 02 clinical trial regimens for FDA study of active cellular immunotherapy for bladder and colorectal cancers in 2012
• Monitors receiving, manufacturing, and shipping to meet the agreed upon schedule
• Review batch records and equipment logbooks for documentation accuracy and completion
• Assist with scheduling and planning of specific chain of identities(COIs) for Day 0 and Day 2 processing
• Facilitated NET/NEO training for new associates
• Assist with scheduling and planning of specific chain of identities(COIs) for Day 0 and Day 2 processing
• Shadowing of Supervisor during critical moments such as power outages, scheduling conflicts, etc.
• Promoted from Associate I to Associate II within one year of employment

Lead Manufacturing Deviation Investigator

Confidential

Responsibilities:

• Within 30 days of Lead Investigator Promotion, personally drove the ER Preventable Rate from 38% to 64%
• Supervised six Coordinators on the Exception writing/Investigation process, provided one-on-one training sessions, taught continuing education classes, trained Coordinators on Personnel Interviewing skills/techniques

Lead Manufacturing Deviation investigator

Confidential

Responsibilities:

• Review and approve investigations prior to submitting to Quality Assurance
• Perform the Initiation, investigative and Corrective Action process for identified MFG Deviations
• Perform follow up CATSWEB MFG training to MOC’s that are new to deviation reporting
• Perform hands-on monitoring of production and non-production activities and notifies area and Quality management of any observed non compliance
• Perform extraction of data from CATSWEB and Qlikview systems for trending purposes
• High level of written and verbal interactive communication skills and working knowledge of FDA and ISO regulations
• Ability to work under minimum supervision and in a team environment
• Ability to read, analyze, and interpret technical procedures and regulations

Confidential, Atlanta, GA

Administrative Assistant/Medical Records Clerk

Responsibilities:

• Conduct coding audits/Quality Reviews
• Ensure compliance with HIPAA and JCAHO
• Answered telephones and channel calls appropriately
• Handled correspondence and word processing
• Maintained files, supplies, postage, and general office condition
• Closed patient clinical records upon discharge
• Perform weekly chart audits and inform appropriate staff of deficiencies
• Provided data entry and clerical support functions
• Medical Coding: Maintain accuracy with medical terminology

Confidential, Atlanta, GA

Back Office Medical Assistant

Responsibilities:

• Interview patients, obtain patient history
• Measure vital signs (blood pressure, height, weight, temperature, chief complaint)
• Drape patients with covering and position instrumentation and equipment
• Track Inventory and order medical/office supplies
• Administer injections and/or treatments, and perform routine laboratory tests
• Operate electrocardiogram and BIO Z machinery
• Schedule appointments, receive monies, perform Administrative tasks

Confidential, Kalamazoo, MI

Certified Sterile Processing and Distribution Technician

Responsibilities:

• Maintain and have a working knowledge of Aseptic Technique
• Provided customer service via answering telephones and call lights
• Clean, assemble and sterilize patient equipment, supplies and instruments according to established procedures and techniques
• Distribution of surgical instruments to operating rooms and departments within the hospital
• Ensured patient areas and rooms were properly stocked and equipped
• Ensured proper storage of sterile instrumentation

Confidential, Kalamazoo, MI

Administrative Assistant/Medical Records Specialist

Responsibilities:

• Confirmation appointments, retrieving triage messages from answering service, returning phone calls, checking patients in/out for treatment, scheduling/sending out new patient information packets
• Medical Transcription (45 wpm)
• Provided support to patients, guest, and staff
• Responsible for obtaining records and copying medical chart information, locating missing medical charts, filing dictated paperwork
• Maintained patient records, census, and identification information in the computer system
• Transcribed physicians’ orders
• Responsible for keeping patient information current and accurate while maintaining HIPPA standards
• Served on a team that created short and long term department objectives in accordance with company goals