This document is a resume for Andrinne Thomas summarizing her 11 years of experience in pharmaceutical supply chain quality assurance and document control. She has worked at multiple pharmaceutical companies including Teva Pharmaceuticals, Shire Pharmaceuticals, and Bechtel Power Corporation. Her responsibilities have included managing change control documentation, maintaining document filing systems, auditing stability reports, and administering technical proposals.
A description of the Audit, Quality and Change Management module in X-Analysis. The module provides detailed metrics analysis of all code and databases running on your IBM i, giving you the power to fully manage quality and change.
A description of the Audit, Quality and Change Management module in X-Analysis. The module provides detailed metrics analysis of all code and databases running on your IBM i, giving you the power to fully manage quality and change.
1. 157 William Penn Dr.
Trooper, PA 19403
Home: (484) 651-3507
andrinnethomas24@gmail.com
ANDRINNE THOMAS
SUMMARY:
11 years Pharmaceutical experience – Supply Chain Quality Assurance
Completed Operational Excellence Advocate Training
Flexible team player emphasizing a collaborative, yet decisive approach.
Trained to ensure compliance with applicable regulatory requirements through data and documentation
reviews and analysis, coordinated auditing activities with Good manufacturing practices (cGMP)
requirements.
Trained on departmental Standard Operation Procedures (SOPs)
TECHNICAL SKILLS:
HRMS, Microsoft Office (Word, Access, Excel, Power Point), Microsoft Outlook, Internet, Typing, Documentum
EXPERIENCE:
01/15 to
02/15 TEVA PHARMACEUTICALS - Horsham, PA
Supply Chain QA Coordinator
Proactively managed the flow of change control documentation into the SCQA department.
Liaise with various departments within the company as well as third party contract manufacturing
organizations.
Managed a variety of administrative functions in a high volume office
Data entry, I received, print and logged change requests in excel.
Maintained records, filing systems and computer files.
Archived GMP documents per Standard Operating Procedures.
12/03 to SHIRE PHARMACEUTICALS - Wayne, PA
04/14 Stability Assistant
Assisted in the organization of product stability testing programs.
Performed stability related functions including tracking of stability pulls and data acquisition.
Maintained a document control system to organize, file and archive stability data.
Maintained regular communication with stability contract testing facilities.
Assisted in the preparation of various ad hoc reports, as assigned, including internal and CMO metrics
reports, NDA Annual reports, Product Quality Review Reports, etc.
Evaluate stability data results to ensure adherence to cGMP guidelines and expectations.
04/03 to SHIRE PHARMACEUTICALS -Rockville, MD
12/03 Document Control Archival Specialist
Registered, scanned, control, distributed, transmitted and filed project records
Audited stability reports (which included checking dissolution, moisture results, appearance, assay,
and impurities test results)
Upon closeout of batch release files, prepared documents for closeout.
Entered employee training records into Microsoft Excel spreadsheets
Recorded master and executed batch records in log book
Logged information from master and executed batch records into Microsoft Excel spreadsheets
2. 157 William Penn Dr.
Trooper, PA 19403
Home: (484) 651-3507
andrinnethomas24@gmail.com
03/00 to BECHTEL POWER CORPORATION / EPCJOBS -Frederick, MD
03/03 Staffing Coordinator (11/01-03/03)
Responsible for maintaining Telecom construction staffing log of 253 employees
Administered Bechtel hiring packages and provided guidance to Bechtel job candidates
Processed requisitions for new hire and transfer employees
Reviewed and tracked resumes for hiring process
Provided staffing assistance to Managers regarding staffing transfers, holds, and processing of
employees.
Interpreted Human Resources Management System regarding information on employees.
Document Control Specialist (03/00-11/01)
Prepare packages for Turnover within scheduled timeframe.
Registered, scanned, controlled, distributed, transmitted, and filed project records using Documentum
Maintained precise and organized filing system
Prepared documents for closeout.
Monitored the market for backlogs and identified inadequacies.
Used standard word processing, spreadsheets, and other office software to support work activities.
Received, date stamped, and distributed incoming mail, packages, and faxes, to appropriate
personnel.
Prepared FedEx labels and packages, as well as used stamps.com for distribution of outgoing mail on
a daily basis
06/89 to LITTON PRC, INC. - Arlington, VA
01/99 Administrative Assistant
Tracked changes to reports
Performed queries and investigations
Administered technical proposals
Responsible for preparation and disbursement of minutes for the Configuration Control Board (CCB)
Provided security support to Program Office for special programs
10/79 to HRB SYSTEMS, INC. - State College, PA
04/89 Advanced Text Processor
Developed technical documentation for commercial, military and in-house specifications
Traveled to various facilities to ensure final and concise order of technical publications
Provided on-site training for personnel
Prepared technical proposals
EDUCATION:
South Hills Business School-State College, PA
Major – Business (1981)
Frederick Community College- Frederick, MD
Major - Criminal Justice (1997)