Data Project

MARK J. ROTH

** ****** *****, *********, ** *****

Home: 203-***-**** . Cell: 203-***-**** . Email: ab84fx@r.postjobfree.com

PROFILE

Auditor/QA Professional with 15+ years of experience in the pharmaceutical

industry. A thorough, detail oriented individual who can see the big

picture and is a team player.

CORE COMPETENCIES

GMP Compliance SOP Development/Revision

Document/Data Review DEA Compliance

Systems Audit Controlled Substance Management

Batch Record Review MS Office

PROFESSIONAL EXPERIENCE

WIRELESS ADVOCATES, Southbury, CT 2011 -

2012

Mobile Consultant

Sold mobile phones retail in Staples Office Supply.

CHARTER COMMUNICATIONS, Newtown, CT 2007 - 2011

Customer QA/Customer Relations Representative, Welcome Center

Made outbound calls to follow up on new installations of service.

. Conducted surveys to determine customer issues.

. Explained services and billing to customers.

. Resolved issues and performed troubleshooting as needed to minimize

service calls.

. Used computerized customer database to find customer information.

WATSON PHARMACEUTICALS, Carmel, NY/Danbury, CT 1991 - 2006

Watson Pharmaceuticals, Inc. (NYSE: WPI) is a leading integrated global

pharmaceutical company engaged in the development, manufacturing,

marketing, sale and distribution of generic, brand and biologic

pharmaceutical products. Formerly Schein Pharmaceuticals, Inc.

Principal Scientist-QA/Support, R&D Operations (2003 to 2006)

Managed and tracked audit of laboratory data for R&D Auditing group.

Prioritized & coordinated audit of R&D Laboratory data with project leaders

& Associate Director of the Laboratory. Performed internal audits, GMP

audits on all types of documents, reports, laboratory data and systems as

needed. Managed review and handling of documents for FDA pre-approval

inspection. Managed R&D controlled substance operation. Supervised two

Auditors and controlled substance personnel.

. Audited a wide range of documentation: including method validation,

method transfer, finished product, raw material and stability

reports/data.

. Conducted audits systems audits and compliance audits.

. Wrote and reviewed Investigation Reports.

. Worked on a corporate SOP team developing and harmonizing corporate

SOPs after merger.

. Created a document auditing SOP which was later adopted as a corporate

wide R&D procedure.

. Coordinated the development of laboratory standards SOP.

. Developed and implemented a data review tracking system using

Microsoft Excel which enhanced the audit process and improved turn

around time.

. Developed and implemented a records management system which improved

security and efficiency of document storage and handling.

. Successfully managed/coordinated the transfer of the R&D controlled

substance operation from Carmel, NY site to Danbury, CT site.

. Developed new procedures for handling controlled substance which

improved DEA compliance.

. Improved DEA & GMP compliance by conducting training presentations for

groups and individuals.

Senior Scientist, Analytical R&D (1998 to 2003)

Scientist, Analytical R&D (1993 to 1998)

. Performed GMP Audit of laboratory test data.

. Managed Document & Sample Control.

. Reviewed documents for FDA pre-approval inspection.

. Generated analytical data packages for submission to ANDA.

Laboratory Auditor, QC-Stability (1991 to 1993)

. Audited laboratory test data for the Stability Department.

. Audited lab reports from outside contractors.

. Audited software validation.

DIVINA PRODUCTS, INC., West Haven, CT 1980 - 1991

QC/Batching Chemist

. Batched multiple products.

. Inspected, tested and released all raw materials, in-process samples

and finished products.

. Review Batch Records

. Supervised two technicians and production line as needed.

TRAINING/TECHNICAL QUALIFICATIONS

Computer:

. Lotus Notes, Microsoft Excel, Microsoft Word, Microsoft Access 97,

Microsoft Project, Millennium (Data acquisition system), Access*Chrom

(Data acquisition system), KMS, ACSR.

Training:

. Project Management

PROFESSIONAL ASSOCIATIONS

American Chemical Society - Member since 1993

EDUCATION

M.S. Chemistry - Southern Connecticut State University ? New Haven, CT.

B.A. Chemistry - St. Anselm College ? Manchester, N.H.[pic]

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