Quality Assurance Specialist

PAUL T. ROGALSKI JR.

ADDRESS: *** ***** ****** * ***** NORTHEAST UNIT 303 WASHINGTON D.C., 20002

PHONE:708-***-****

E-MAIL: adfw27@r.postjobfree.com

QUALITY ASSURANCE SPECIALIST

CAREER SUMMARY

Driven, dedicated, and hardworking team player who will actively monitor organization compliance and will ensure quality performance through direct oversight, technical advice and counseling. Trusted advisor and team contributor who builds relationships with internal and external stakeholders to improve performance and agreed metrics. Achieves project objectives and business goals with limited time and budgetary restraints.

SKILLS

• Strong Communication

• Pays close attention to detail

• Product Development

• Process Design

• Process Improvement

• Critical Thinking

• Data Analysis

• Professional Presentations

• Planned Events

• Ability to Work Under Pressure

• Decision Making

• Time Management

• Self motivation

• Conflict Resolution

• Leadership

• Adaptability

• Teamwork

• Creativity

PROFESSIONAL EXPERIENCE

KIK CUSTOM PRODUCTS PERSONAL CARE DIVISION, Rosemont, IL 04/18-Present Regulatory Affairs Specialist

• Developing relationships with Global Supply chain and regulatory bodies to ensure cosmetic, over the counter (OTC), and medical device compliance, while managing regulatory risk in a complex global regulatory environment comprised of risk assessments and internal audits.

• Each year have registered nine manufacturing sites and 200+ OTC drug products using Food and Drug Administration's Center and Drug Evaluation Research (CDER) Direct system.

• Reviewed and approved 150+ finished good labels, packaging, ingredient lists, bills of material, technical data sheets, and dossiers to obtain approval and bring new or modified products to market.

• Coordinated in the development of 150+ Safety Data Sheets for new and revised finished goods.

• Experience includes Food and Drug Administration, State Pharmacy Boards, Health Canada, European Union, Australia’s Therapeutic Goods Administration, and Association of Southeast Asian Nations.

ABBOTT LABORATORIES/COLLABORATIVE LLC (CONTRACT), Des Plaines, IL 06/17-04/18

Project Quality Manager

• Provided support to ongoing Quality Assurance projects for the global organization, particularly in Supplier Quality, Document Control and • Training producing the highest quality results for Trackwise project while operating within the constraints of the business timelines and guidelines.

• Accountable for the integrity and maintenance of the Abbott Molecular Division Document Control and Record Retention system, both electronically and manually, including storage and retention.

• Successful launch of Trackwise project plan. Developed a project plan, coordinated with functional area owners creating 55 change requests meeting milestones. Recognized for an Excellence Award in achieving.

• Pulled metrics together for Supplier Quality Audits and Corrective Actions to meet deadlines.

ASTELLAS PHARMACEUTICALS/RANDSTAD (CONTRACT), Northbrook, IL 05/16-01/17

Clinical Supply Project Coordinator

Provided support to clinical project management teams identifying the opportunities for the reconciliation and destruction processes.

• Communicated effectively with suppliers in order to receive depot reports which helped Clinical Trial to assist with study reconciliation, resolved vendor issues and reconciliation discrepancies.

•Evaluated return stock of 15 studies, which contributed to 27% of destruction. As a result, saved the company thousands.

ABBOTT LABORATORIES/COLLABORATIVE LLC(CONTRACT), Des Plaines, IL 08/14-05/16

Quality Specialist II

• Provided support to the Global Supply Chain Quality team collaborating with multiple groups within the organization continuing to work on projects related to the supply chain and incoming quality control.

• Monitored external change notifications of 75 suppliers. Minimized backlog of more than 500 supplier change notifications by 80% which exceeded the goal by 30%.

• Facilitated bi weekly meetings, with team leaders from Technical and System Product Support, Engineering, Design Transfer and Purchasing, to discuss the impact change notifications have on planning and production.

• Provided follow up and delivery of weekly status reports and metrics to track and trend supplier change notifications and incoming quality control using SharePoint and Excel.

YOUNG INNOVATIONS, INC., Algonquin, IL 02/08-10/13

Quality Assurance Analyst

• Contributed to the development of the endodontic product quality management system by developing policies, procedures and work instructions to assure compliance with International Standards Organization(13485:2003), Japan Pharmaceutical Affairs Law, Occupational Safety and Health Association, Code of Federal Regulations, and Food and Drug Administration regulations regulatory bodies.

• Performed statistical data analysis of key product and process variables for broad quality objectives and single data units utilizing Excel, Access, and SQL.

• Reviewed 10-K Forms for new product launch of Obtura Max Root Canal System.

• Prepared and presented presentations data trending and managing quality objectives, complaints, corrective action, document change requests, and non conforming material for quarterly quality reviews.

EDUCATION/AFFILIATIONS/ACTIVITIES

B.A., Communications/Public Relations, University of Dayton, Dayton,

OH, 12/07

Member of Regulatory Affairs Professional Society (RAPS) 06/18-Present Member of American Society of Quality (ASQ) 06/16-Present

Computer Proficiency: Microsoft Office, Access, Excel, PowerPoint, Photoshop, Project, SQL, SharePoint, Visio, SPSS, Trackwise, Pilgrim SmartSolve, Document Records System, Avante, MAS90, Great Plains, ACT, Goldmine, JD Edwards, UL WERCs, Macola, Coptis Research and Development Tool, Blue Marketing Software, CDER Direct

Community Service: Volunteer work for Higgins Physical Medicine, the Willow Creek Care Center, Feed My Starving Children, Big Brothers Big Sisters, and the Big Shoulders Fund. Avid Runner: Completed seven marathons, fourteen half marathons, five relays, and multiple events with the Dick Pond Athletics Fast Track Racing Team.

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