Management Quality

Jacqueline Baisley

** ***** ********* ********** *****, N.Y. 12590

Phone: 845-***-****

E-mail: ********@***.***

Objectives

Seeking a position that employs my scientific abilities and enhances my organizational skills

Education

Master of Science Environmental Science and Occupational Health

New York Medical College Graduate School of Health Sciences (2001)

Bachelor of Science Biology

State University of New York College at New Paltz (1988)

Experience

Quality Analyst, Analytical Services (April 2005 –July 2017)

TEVA Pharmaceuticals (Pomona New York)

Labware LIMS-(ORACLE platform) System Management and Maintenance:

Configures product specifications, provides system support, technical solutions/guidance, and maintenance of LIMS for the Quality Control Department.

Provides trouble-shooting expertise and end-user support for all LIMS system activities.

Reviews and approves LIMS product specifications

Reviews TrackWise change controls for LIMS related specification updates as appropriate.

Interfaces with key QC and site personnel to ensure most optimal cycle and lead time for laboratory operations

Drives necessary improvements in these areas to improve the overall efficiency and effectiveness of laboratory systems.

Works closely with IT Quality group to provide user support and in order to ensure smooth transition to new version of Labware LIMS v7.

FirstDoc Wisdom and Harmony Trackwise Systems

Reviews and approves product specifications and Analytical Methods within Wisdom to ensure compliance to internal requirements and external guidelines and regulations.

Creates change controls in Trackwise for Labware LIMS updates associated with these specification and method changes.

Drives change controls to completion so that projects remain in compliance with departmental SOPs.

Scientist II Analytical Information (October 1996-June 2004)

Analytical Quality & Science, Stability Wyeth Research, (Pearl River, NY)

PE-Nelson SQL*LIMS- (ORACLE platform) System Management and Maintenance:

Specification, stability, and instance record management, including change control administration.

Supported Pharmaceutical Sciences and specification committee to address LIMS template issues insuring rapid response to development issues.

Provided LIMS user training and troubleshooting as needed.

Interfaced with IT, R &D management and multiple users to improve LIMS functionality.

SQL*LIMS 4.1 Validation & Training

Participated in SQL*LIMS 4.1 Development Project from inception to completion

Prepared LIMS Validation Documentation for SQR and Brio Reports

Developed Training Manuals for A R&D and Stability Departments

Trained staff within stability department on SQL*LIMS upgrade.

Provided user support and troubleshooting to ensure smooth transition to new version of SQL*LIMS

Skills

Strong understanding of cGMP and cGxP for validated electronic data systems in an analytical laboratory environment

Demonstrated knowledge of stability study management, assisted with data review and stability report review for NDA submissions

Experience working in culturally diverse, multi-disciplined work groups.

Keeps accurate records in accordance with SOP and cGMP requirements

Capable of managing multiple priorities in a fast paced setting

Experience writing ad hoc queries using Toad for Oracle.

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