Medical Device Project

Lynne Ricicki, MPH

732-***-**** acd8x4@r.postjobfree.com

** *** ****** **********, ** 07960

OBJECTIVE: Creative, critical thinking and passionate professional with 4+ years of experience in environmental health

and safety with expertise in the interpretation and application of regulations is seeking a regulatory/ quality

compliance position.

EDUCATION: Master of Public Health

Concentration Environmental & Occupational Health

University of Medicine and Dentistry, October 2012, GPA: 3.8

Masters Research: Assessed public exposure and health risk to water contaminants by modeling predicted

pharmaceutical concentrations as compared to pre-measured concentrations.

Bachelor of Science

Concentration Environmental Policy Institutions and Behavior

Rutgers University, School of Environmental and Biological Sciences, May 2010, GPA 3.9

EXPERIENCE:

04/13-

05/14 Ethicon, A Johnson & Johnson Company, Somerville, NJ

Quality Analyst I

Litigation Project Management:

- Follow FDA guidelines to ensure that litigation claims are submitted accurately in accordance with

compliance deadlines

- Create and enter product complaints and adverse events into various databases, choosing the

appropriate report types

- Engage with teams of medical professionals to question and confirm patient information.

- Assist with preparation for FDA audits

- Lead on boarding and training for new contract employees assigned to project using Remetrex and

Siebel Software

- Distribute workflow to new employees and review finished work products and provide detailed

employee performance metrics to management

01/13-

04/13 BASF, Florham Park, NJ; Ecology Health & Safety (EHS)

Environmental Product Information Center (EPIC) Specialist

- Provided EHS product regulatory information to customers to support select business units that

respond to over 300 requests per month

- Used SAP (BASIS), Ariel web database, Substance Data Sheets (SDSs), and Technical Data Sheets

(TDSs) to find information and draft responses for customers

- Submitted timely and accurate reports to the FDA

- Ensured delivery of accurate and timely compliance information regarding FDA clearance,

physical product properties, REACH status, Global Inventory Status, substances of concern, and

other inquires

- Maintained and update regulatory databases

- Provided product stewardship support

01/09-

06/12 Johnson & Johnson Corporate, New Brunswick, NJ

Worldwide Environmental Health, Safety & Sustainability Intern (WWEHSS)

- Facilitated the WWEHS department’s implementation and expansion of sustainability, product

stewardship and green marketing initiatives across Johnson & Johnson’s operating companies

- Drove the expansion of Johnson & Johnson’s EARTHWARDS™ process to develop more

environmentally and socially sustainable pharmaceutical, consumer and medical device products,

leading to over $2M in estimated EARTHWARDS™ designated product sales in 2011

- Led product teams through EARTHWARDS™ product recognition to reach companywide product

stewardship goals

- Ensured quality in all parts of the process for review during annual third party audits

- Redesigned and streamlined sustainability communication materials including design of a new

internal website, brochures, logos, and presentations, making information regarding green marketing

easily accessible to all J&J employees to further drive sustainability efforts

- Used Google Analytics to track use of websites and green marketing materials

- Completed detailed review of ISO 14020, 14021 (environmental labeling and self-declarations) to

ensure J&J’s regulatory environmental compliance of the EARTHWARDS™ process

- Conducted training on EHS programs, compliance and tools

- Analyzed and assessed annual sustainability, green marketing reports (Shell, Neilson, Cohen) and

EHS data

ACTIVITIES:

The Sustainability Collaborative: Communications Co-Lead-

-Developed succinct messages to include in public materials.

-Conducted an in depth research project using key search terms. Reviewed over 40 websites for best

practices, backlinks, and social media utilization.

Frog Lotus Yoga, Certified Hatha and Vinyasa Yoga Instructor (200 hour)

-Study of yogic history, philosophy, anatomy, asanas (poses), and pranayama (breath).

SKILLS:

Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Access, Microsoft Live

Meeting, Adobe Premiere, SharePoint, SAP, SPSS, Lotus Notes, CHATS, Siebel

Contact this candidate