SHARON CANNON

Residents in both PA and FL • cannons127@live.com

(Cell) 610-368-5886

SUMMARY
A position in Quality Assurance within the biotechnology/biopharmaceutical industry. Background
includes: developing and implementing quality electronic documentation systems; review Batch
Records, laboratory logbooks, SOPs, and training files; experience interfacing with the FDA; sound
knowledge of cGMPs, GLP and FDA policies and guidelines for pharmaceutical/biotechnology
products.

PROFESSIONAL EXPERIENCE
AVAX Technologies, Inc., - Philadelphia, Pennsylvania 2009 to Present

Manager, Quality Assurance

Facility was closed for the last six year; my main project is to bring facility back online, for the
production of vaccine. Responsibilities include:
• Preparation of the companies QA manual control and supervision of all amendments and
revisions.
• Control and distribution of all the companies quality documentation
• Monitor all quality related activities on projects.
• Perform all internal and external audits on behalf of the companies management
• Develop, Training Program for staff of 10 employees, which include group training sessions
for GMP compliance, running monthly reports for employees to advise of upcoming training
requirements. Maintain training file for each employee.
• Verify contactor quality requirements and specified to vendors and contractor documentation
submittals.
• Prepare and control project quality system management documentation prior to project
commencement.
• Review quality inspection personal qualification and training requirements.
• Monitor the disposition of all issued nonconformance reports.
• Coordinate all QA/QC activities with the site QC manager.
• Control all achieve documentation upon the completion of projects.
• Review site purchase orders to ensure that the applicable requirements are met.
• Ensure the verification of documentation and certificates for materials purchased by vendors.
• Create; revise Standard Operating Procedures (SOPs), Batch Records, Forms, Protocols,
etc….

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Professional Experience Continued

Tengion, Inc, – E. Norriton Pennsylvania 2008 to 2009

Sr. Document Control Specialist, Quality Assurance
GMP Document Control System
• Maintain robust and comprehensive GMP Document Control System including; document
retrieval, distribution and archival.
• Implemented EDMS (Electronic Document Management System) including: User training,
providing administrative and technical support for 2 sites.
• Quality Assurance Review and technical reviewer of Documentation (SOPs, Batch Records).
• Mange database for GMP Documentation and Training Files.
• Perform internal audits of Document Control system and related functions.
• Provide technical support for regulatory functions related to FDA filings, inspection activities,
and reports to agencies.
• Proofing and editing Standard Operating Procedures, Forms, Validation Documents
(Protocol Qualification, Functional Design Specifications, and User Requirements
Specifications) prior to routing for approval.
• Create new and revise current policies and procedures for periodic reviews.
• Performed PQ, Validations for the following systems: EDMS (Electronic Document
Management System).
• Environmental Monitoring Class 10K and 100K Manufacturing Areas; Gown Qualified,
Sampling, reading data.

GBSC, LLC. Johnson & Johnson – Malvern, Pennsylvania 2001 to 2008

Documentation Specialist/Records Retention Coordinator
GMP Documentation
• eDoc (Electronic Document Management System) Super User for entire Process Technology
Department consisting of 122 individuals as well as back up for other departments in
Malvern.
• Reviewed and revised BLAs prior to electronic submission for Regulatory Affairs.
• Created templates used in documentation, proofing and editing technical documents, work
instructions, SOPs and forms prior to routing for approval.
• Create, revised Batch Records, Forms, SOPs, Protocols and Reports.
• Team Member for BLA’s, consisting of reviewing and revising sections of the BLA
• Performed PQ Validations for the following systems: Documentum, ISOTrain, eDoc, and
ComplianceWire.
• Preformed internal Quarterly QA audits of Documents, Policies, Procedures, Training files
and related functions.

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Record Retention
• Coordinator for the Department. Responsible for creating, updating and maintaining Record
Retention Schedules and Hold Notices.
• Member of the Records Retention Policy & Procedures team. Create and update policies
and procedures for the company on Record Retention, Litigation and Hold Notices.

Freelance Pennsylvania, New Jersey, New York and California 1997 to 2001
Associate Producer & Production Coordinator
Produced Commercials for TV, and Cable, Corporate Training Videos and Infomercials.
Responsible for hiring crew of 5 to 100 individuals for productions, and payroll
Responsible for budgeting projects between $10,000. - $10 Million
Negotiated contracts with studios, equipment rentals, SAG for actors and Local Unions
• Proof and rewrite scripts

Health Partners, Inc. Philadelphia, Pennsylvania 1993 to 1996

Coordinator Advertising, Promotions and Production
Promoted from Administrative Assistant to Coordinator Advertising, Production and Promotions after
6 months. Collaborate with Sales & Marketing Manager to create strategic plans to enhance
promotion and marketing materials. Work closely with Community Affairs, and other departments to
promote community events, contests, and clarify information reports.
• Negotiate contracts for print and electronic media.
• Produced sales, marketing and promotional materials.
• Proof all print, electronic media, marketing materials prior to production.
• Coordinated approval of sales, marketing, promotional materials, print and electronic media
with the State prior to release.
• Wrote and distributed PSA’s to local Radio Station for community events.
• Coordinate Health Fairs, Community Events and Trade Shows.
• Performed PQ Validations of new software system for use in the company.

CTS Cardiac & Thoracic Surgeons Philadelphia, Pennsylvania 1990 to 1993

OR Coordinator
• Organized (4) Open Heart/Lung OR’s for daily and emergency surgery.
• Coordinated ER transfers from area hospitals for open heart and heart transplants.
• Responsible for checking insurance and obtaining precertifications prior to surgery.
• Produced weekly and monthly mortality and morbidity reports for Chief Surgeon and Hospital
Administrators.
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Professional Experience Continued

Weber County Mental Health & Drug Center -Ogden, Utah 1989 to 1990
Administrative Assistant
• Supported VP and Sr. Manager
• General office duties
• Facilitate weekly staff meetings with staff and Sr. Manager, produced minutes of meeting and
follow-up.
• Coordinate off-site quarterly meetings normally held during lunch or dinner.
• Produced monthly progress reports of patients to District court, Attorneys and insurance
companies.

Upward Bound Program - Ogden, Utah 1986 to 1989

Administrative Assistant (April 1986- June 1986) Coordinator (June 1986 –1989)
This was a 35-hour week position while attending college full time, 40 hours during the summer.
Working with High School student from socially ergonomic deprived families. The program offered
free counseling and tutoring with homework. The summer program consisted of 8 weeks that
offered classes in writing and math for students to increase their skills, high school graduates are,
offered the opportunity to enroll in 1 college course. I was promoted from Administrative Assistant to
Coordinator after 3 months with the Program.

• Supported Director of the department and staff of 20.

• Interfaced with student and counselors to identify needs, questions, and resolve issues as
needed.
• Ready documents, student files for State Audits each year.
• Provide information to parents and students of the program and what it has to offer.
• Coach and mentor students in career choices and college education.

EDUCATION AND TRAINING

Dual Bachelor of Sciences in Sociology & Psychology • WEBER STATE UNIVERSITY – Ogden, Utah
• G.P.A.: 3.9
• Secretary for PSI CHI National Honors Society of Psychology
• Member of the Rodeo Team
• Completed Greenbelt Training 10AUG05 (Completion of project September 2007)

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SKILLS

• Type 75wpm
• Proficient in: Documentum, eDoc, ComplianceWire, Microsoft Office; Access, Excel,
PowerPoint, Project, Publisher, Word, Outlook and Visio, Adobe Photoshop, Corel Draw
• Sound understanding of cGMP, GLP and FDA polices and procedures
• Internet Savvy

REFERENCES

Available upon request