Quality Assurance, Regulatory Affairs, Biotech

DOMINIC C. JONES

Telephone: 267-***-**** Email: *******.*******.*****@*****.***

Address: *** *. **** **., ***. 2R, Philadelphia, PA 19139

PROFESSIONAL EXPERIENCE

Malvern, PA October 2010 – Present

FUJIREBIO DIAGNOSTICS INC.

QUALITY ASSURANCE ANALYST, QUALITY ASSURANCE

Prepared and reviewed the necessary documentation used in the manufacturing of final product to

assure overall compliance with internal specifications, customer/partner specifications, and FDA

regulations.

Audited batch records, labeling and packaging documents, etc… for correctness and

completeness according to appropriate SOP’s.

Determined the disposition (release/reject/approve/etc of products and components and

logged completed documents into the Quality Data Interchange System (QDI).

Issued labeling and packaging documents through QDI.

Tracked document error rates and other metric indicators of quality assurance

performance.

Maintained, archived, and provided lot history files upon request.

Participated in Q.A. improvement and training projects.

December 2009 – April 2010

INTERNATIONAL FLAVORS & FRAGRANCES Dayton, NJ

DOCUMENT CONTROL, QUALITY ASSURANCE

Participated in the development, coordination, and global maintenance of technical specifications

within the Quality Assurance SAP (Quality Management) and CPD computer systems.

Maintained and issued FDA Legal Status / US Ingredient Declaration, Nutritional Profile,

and NAFTA documents.

Organized and filed Specifications and Customer Account documents.

Modified Inspection Plans and checked / tracked R&D and plant recordings upon request.

Provided technical liaison and timely follow through with internal and external customers

on issues related to Quality Assurance supplied documentation.

Understood corporate safety requirements, maintained safety awareness.

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Philadelphia, PA March 2009 – October 2009

IROKO PHARMACEUTICALS

DOCUMENT CONTROL, QUALITY ASSURANCE

Maintained Quality Assurance documents through printing, processing, circulating, and filing.

Retrieved Quality Assurance documents upon request.

Handled a variety of documents including Batch Records, Specifications, Certificates of

Analysis and Conformance, Deviations, Investigations, Audit Reports, and Standard

Operating Procedures.

Entered information into and maintained an MS Access database.

Prepared file labels and binders, issued tracking numbers, and filed documents.

Wayne, PA October 2008 – February 2009

OCTAGON RESEARCH SOLUTIONS

REGULATORY ASSOCIATE, REGULATORY OPERATIONS

Published Regulatory Electronic Submissions

Trained in the Submission process of the FDA and in the Scanning and Image

Enhancement of submission documents.

Preformed initial RO review of Case Report Forms to ensure submission-readiness.

Published Case Report Forms (created bookmarks and hyperlinks) in accordance with

ICH and FDA Guidance’s.

Utilized in-house software to produce all submission documents in electronic format and

preformed quality control and quality assurance on all submission documents.

COMPUTER SKILLS

MS Office (Word, Excel, PowerPoint, Outlook), Lotus (Email), Adobe Acrobat (Document Editing),

IBM Documentum (File Management), SAP, Oracle Quality Data Interchange (Disposition Materials,

Issue Documents), Sparta Track Wise (Nonconformance, Customer Complaint Tracking)

EDUCATION

BS Health Policy and Administration, BA Sociology, Pennsylvania State University

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