PROFESSIONAL EXPERIENCE

Keywords: drafting technical documents, researching regulations and procedures, summarizing FDA regulations, technical and medical writing, editing and writing SOP's, adhering to GMP and GLP, Sharepoint proficiency, gathering and analyzing data, Adobe Acrobat, Microsoft Office Suite, Visio, Microsoft Access, personnel training

Confidential

Gathering information from domestic and international manufacturing and regulatory subject matter experts, as well as batch records, validation reports, regulatory data and other documentation to complete criticality analysis reports. Translating batch records using online translating tools. Formatting criticality analysis for entry into Docspace. Uploading, editing and writing technical documents for legacy products including tablets and creams in Sharepoint. Electronically routing documents using Docspace/Documentum Compliance Manager. Providing status updates, setting up meetings with local and international team members to review report progress and gather information from team members. Reviewing report template. Assisting with editing and other projects as needed. Providing guidance and assistance on document routing and updating to extra-departmental groups. Performing personnel training.

Confidential

Technical Writer

Drafting and editing functional specifications based with assistance from the compliance plan, drafting report test plans, working with user requirements and database design documents in order to create functional specifications. Writing meeting minutes updating team members on deliverables and deadlines, updating project manager on the project status.

Confidential

Technical Writer

Editing manufacturing-related procedures, researching and gathering domestic and international SOP-based terminology in order to assist in terminology standardization in the manufacturing area, initial drafting of technical research documents, maintaining project progress by scheduling and attending progress meetings, assisting in maintaining edited drafts on Sharepoint.

Confidential

Freelance Writer

Creating informational articles on health and science related issues. Specific topics include scientific testing, nutrition, and disease.

Confidential

Technical Writer

Prepared the plant for a Safe Quality Food SQF audit by editing and writing standard operating procedures SOPs electronically for the various manufacturing departments. Summarized FDA regulations related to food handling. Met with quality managers in helping to gather information related to the updating the SOP's. Aided the quality lab in getting information and updating product information in the database.

Confidential

Lab Associate

• Performed testing on production trials for application/research and development lab
• Tests included: particle size determination, color change determination using photospectrometer, viscosity measurements using a rheometer and pH readings.
• Fulfilled both plant, regional and international requests from other team members for sample testing.
• Prepared and participated in tastings to determine shelf-life quality of products.

Confidential

Microbiologist

• Managed lab during shift by performing duties including testing product samples and raw materials, tested productions lines to determine their level of sanitation, oversaw sanitation when tests fail, and conducted training as needed.
• Checked package labeling and trouble-shooted labeling and packaging issues.
• Presented monthly GMP training topics to operators and shift management. Trained other quality personnel.
• Performed tests include shock, Babcock, titratable acidity, performance, flavor, and specification among others tests and inputted results into database.
• Supported production of Reddi-Wip following machine maintenance to ensure product quality.
• Completed projects related to product quality assurance such as weight testing and new product fats and solids. Responsible for placing questionable product on hold when deemed appropriate. Communicated to management problems with product during periodic testing. Troubleshot production problems and general facility maintenance issues.
• General lab maintenance and calibration of specific lab equipment.
• Inventorying lab supplies.

Confidential

Project Assistant Parenterals

• Supported Lilly oncolytics and antibiotics through assisting with validation
• studies.
• Editor for master formulas and inputting edits into a database.

Responsibilities included:

• Supported preparation of annual report submission documentation to FDA.
• ADMIN/LIMS computer system, submitting samples to the laboratory, second person verifying of study calculations and text. Technical validation and preparation for technology transfer to new facility for Alimta.
• Assisting in Six Sigma project to streamline manufacturing tickets by reducing errors, editing and routing validation documents, obtaining samples for validation studies, preparing lab submission through use of the
• Verification of stopper integrity and dimensions for parenteral studies and

investigations.

Laboratory Technician

• Followed FDA regulations in order to maintain the integrity of the
• specimens such as proper specimen temperature, accurate recording of
• information, noting any specimen discrepancies to supervisor.
• Cataloged clinical trial specimens using highly specialized computer
• system used to track and record specimens.

Confidential

Microbiologist III

• PCR Expertise - Tested chlamydia and gonorrhea specimens on Genprobe
• instruments. Generated patient results via computer, reviewed results and
• verified patient information, assisted with lab supply purchases, and performed
• quality control.
• Validated urine specimens using Genprobe instrumentation. Assured cell
• line purity prior to inoculation with herpes or flu specimens. Inoculated
• flu and herpes specimens in viral media. Attended continuing education
• seminars, i.e.CDC-sponsored audio conferences about disease outbreaks including
• SARS. Trained new lab personnel on routine techniques.

Confidential

Medical Lab Supervisor

• Trained medical assistants.
• Tested patient specimens, conducted stat tests and distributed patient results to
• medical providers.
• Maintained quality control and performed Cholestech LDX, Clinitek, DCA
• 2000 and Coulter cell counter in addition to associated kit tests.
• Provided pertinent patient data to reference labs via computer or
• Manual requisitions. Ordered specimen pick-ups and conducted patient check-in, blood draws, scheduling, and consultation.
• Confidential
• Participated in protocol meetings during the study development process to ensure
• FDA and good clinical practice guidelines were followed.
• Authored an article on medical writing careers.

Confidential

Infectious Disease Research Intern

• Conducted research involving a hepatitis C protein, which required the use of
• recombinant DNA technology, bacterial sonication, silver staining, western
• blot, gel electrophoresis, centrifugation, enzyme-linked immunosorbent assay
• ELISA , spectrophotometry and data collection.
• Participated in weekly meetings with the senior investigator, Q. May Wang, Ph.D.

Confidential

Student Research Assistant

• Collected blood samples from caprine encephalitis virus-infected
• goats. Prepared and ran agarose gel electrophoresis.
• Edited publications and various research-related documents, including a
• Graduate thesis and grant proposals.

Student Research Assistant

• Organized grant proposals and other documents related to various
• scientific projects.
• Prepared a poster presentation for a biology department competition with
• funds received from the primary investigator, Dr. Dalton McWhinney.

Confidential

Summer Student Research Assistant

• Conducted research in the lab of Dr. David A Schwartz on grain dust
• induced airway disease. Performed techniques necessary for the project
• including bronchoalveolar lavage, retro-orbital injections, cell counting, lab
• mice handling, generation and interpretation of computer data, ELISA and

plethysmography.