Katy Mussey: Freelance Make-up Artist/ Actor/ Writer in Tustin, CA

Currently accepting freelance positions including: creative writing, copy writing, technical writing, technical editing, creative content, marketing/promotions, screen writing, visual comedy, public communications. - Writing for personal blog/ book at http://katyinthemiddle.tumblr.com - Featured on Zooey Deschanel's website "HelloGiggles". -Assisting in multiple college-based films/theatre – acting, production, script writing, casting and lighting. Most recent credits include a lead acting role for "Almost Maine" with the Clague Playhouse in Westlake, Ohio and serving as Lead make-up artist for Gospel Stage Production of "The Devil Is a Liar!"

-Assisting in all transfer activities of ANDAs including redaction, management review of redacted ANDAs, tracking for all labeling materials and databases, etc. -Managing/updating information for Annual Reporting for labeling components. -Maintaining all labeling for post-approval submissions. This includes content editing/copy writing/review of text inserts, labels and cartons as well as graphics such as brand logos for a 100+ product portfolio. Proficient in SPL and PLR (Physician’s Labeling Rule). -Creating new labeling for ANDA submissions. This includes construction of labels, cartons, inserts, SPLs and QbR documentation. -Managing/ editing/ approving Regulatory aspects for the Advertising and Promotional materials submitted to the FDA. This also includes updating the marketing for catalogs, company website, DailyMed, brochures, etc. -Responsible for Regulatory Affairs labeling budget in regard to pre-press costs such as artwork and production proofs. -Updating and maintaining SOPs and guidance material for labeling group.

-Maintaining all Bedford Laboratories labeling for post-approval submissions. This includes content editing/copy writing/review of text inserts, labels and cartons as well as graphics such as brand logos for a 100+ product portfolio. Proficient in SPL and PLR (Physician’s Labeling Rule). -Creating new labeling for ANDA submissions. This includes construction of labels, cartons, inserts, SPLs and QbR documentation. -Managing/ editing/ approving Regulatory aspects for the Advertising and Promotional materials submitted to the FDA. Pioneered Marketing database to track progress throughout the facility for Advertising, Regulatory and Quality changes. -Communicating with contract customers to support contract labeling and making revisions as needed. Serves as solitary contact for labeling required by NCI (National Cancer Institution). -Working with vendors on all pre-press activities including prioritization based on the manufacturing schedule for both Bedford and Contract products. -Responsible for Regulatory Affairs labeling budget in regard to pre-press costs such as artwork and production proofs. -May communicate with internal and external resources including FDA in regard to labeling issues. -Continuous record of exceeding goals 2 years in a row in accordance with company development plans.

-Drafting, reviewing and researching scientific documentation for the Quality Systems Department (Technical Writing, Change Control, Complaints, etc). This included Standard Operating Procedures, Batch Records, Customer product complaints, Adverse Events. -Assisting the Training Department with company-wide communication initiatives including orientations and Lectora computer-based training modules (safety videos, instructional courses, New Hire Orientation, etc). -Maintaining customer complaint database through the Trackwise System and working directly with the Quality Investigators to provide the correct and in-depth information needed for investigations (Trending reports, queries, supporting documentation, etc.) -Lead team member for the Annex 1 Filtration Project and Field Alert Status Team. Pioneered Validation Database which supplies all records involving filter validations, extractables, compatibility and viability reports onto a single template based out of development records.