Ryan Rusak

Totowa,NJ 201-***-**** acxlrh@r.postjobfree.com

Professional Profile

Document Control » Quality Assurance » Publishing Workflows

Service-oriented, analytical, and extremely versatile pharmaceutical document control and quality specialist; proven track record meeting project deadlines and exceeding stakeholder expectations.

Successfully assimilates and integrates new technology and terminology, and consistently seeks opportunities to add value in a collaborative team environment.

Excels under pressure, delivering high quality work under challenging time constraints with rapidly shifting priorities, and offers a strong working knowledge of clinical trial operations.

Strengths and Qualifications Include:

Document Maintenance & Change Control Imaging & Archiving HTML Indexing Document Processing & Compliance

Quality & Process Improvement Communication & Collaboration Data Entry & Validation Status Tracking & Reporting

Technical Skills: Microsoft Office – Word, Excel, PowerPoint, ISI Toolbox, DocComposer; Adobe Acrobat, Pagination

Mallinckrodt Pharmaceuticals, Hampton, NJ August 2016 – November 2016

Maintains physical and electronic documents and ensures files are effectively organized.

Reviews transmitted material and accepts or rejects the material in accordance with established procedure.

Performs documentation formatting and word processing according to sponsors approved style guide and documentation standards.

Assists in the tracking, archival and retrieval of regulatory submissions following instructions from supervisor.

Responsible for the collection, scanning, filing in EDMS as appropriate.

Home Depot., Parsippany, NJ May 2016 – August 2016

Assisted customers in finding merchandise, provided assistance to members of seasonal department.

ALVOGEN PHARMA., Pine Brook, NJ December 2015 – February 2016, Document Control Specialist (Temp)

Wrote bookmarks and hyperlinks for FDA submissions, Updated and logged correspondence from FDA.

PURDUE PHARMA, L.P., Totowa, NJ October 2014 – March 2015, Document Control Specialist (Contract)

Verified, packaged, and archived FDA submissions for the centralized document control office of Purdue, and provided training on all aspects of document management to new team members.

Created and maintained detailed progress logs, and presented timely updates on progress and potential roadblocks to department managers.

MERCK, INC. (LIQUENT), Rahway, NJ January 2013 – March 2014, Document Control Specialist

Coordinated the publishing workflow; uploaded case study reviews and protocols into Merck’s proprietary RCAM database as a full-time Liquent-employed clinical trial resource.

Authored SOPs and user guides for numerous procedures, including CSR uploads and PDF properties, and responded to ad hoc requests for the scientists and other clinical/non-clinical stakeholders.

RANBAXY, INC., New Brunswick, NJ July 2012 – January 2013, Documentation Specialist (Contract)

One of the first employees in the newly created Office of Data Review, played an instrumental role in data review and scanning projects for FDA response.

Implemented and evaluated efficacy of new process flows and documentation guidelines in concert with both US-based and headquarters management in India.

LABCORP, INC., Raritan, NJ February 2012- July 2012, Data Entry Specialist (Contract)

Reviewed and entered a high volume of patient records for the outsourced employee pre-hire testing division of LabCorp.

Certified accuracy and availability of all patient data, and discretely handled confidential records. Ensured alignment with all HIPAA requirements and client-specific service agreements.

EISAI, INC., Woodcliff Lake, NJ March 2009 – September 2010, Document Specialist (Contract)

Retained on back-to-back contracts; bookmarked, and archived files for acid reflux and Alzheimer’s studies.

Served as the QA specialist on FDA submissions, and processed QA/batch records in compliance with FDA regulations and internal quality standards.

Various Pharmaceutical companies 2006-2009

Robert Half International, Parsippany, NJ (2009)

Image Solutions, Whippany, NJ (2007-2009)

Express Scripts, Lincoln Park, NJ (2006-2007)

Education

DAVIS & ELKINS COLLEGE, Elkins, WV – Bachelor of Arts (BA), History; Minor in Business Administration (2005)

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