Quality Assurance

MARISOL ESTELA

**** ********* ****** *** ~ Bethlehem, Pennsylvania, 18015

**********@*****.***

Home: 484-***-****

PROFESSIONAL EXPERIENCE

FMI, Allentown, Pennsylvania 2011 - Present

Quality Control/Quality Assurance

0. Ensured cGMP compliance in all areas and update procedures accordingly.

0. Investigate and report on all non-conformance and quality issues and

place non-conforming product on hold; identify root causes.

0. Inspect incoming components and raw materials

0. Conduct line inspections and packaging audits on up to seven lines

0. Testing of incoming finished mixes for odor and appearance against

standards and additional testing for specific gravity, viscosity, GC

analysis and refractive index, FTIR

0. Prepare samples to send to outside lab for products requiring additional

micro testing.

0. Review and release of mix sheets and packaging worksheets

0. Perform weekly stability on product development and first time

production batches.

0. Perform packaging compatability studies for new products

0. Train new technicians

FEDEX HOME DELIVERY, Bethlehem, Pennsylvania 2009 - 2011

Route Driver

0. Scanning packages and loading them into truck according to number

sequences.

0. Obtain daily manifests, turn by turn directions and maps for daily route

deliveries.

0. Perform pre and post trip inspections of truck

Driving P-500 truck, in a professional and safe manner and delivering

packages to customers and obtaining signatures.

0. Responsible for scanning all packages before release to customer.

0. Perform end of day close out signing of final reconciliation paperwork.

TEVA PHARMACEUTICALS., Fairfield, NJ / Sellersville, PA 2006 - 2009

Assistant Engineer / Associate Engineer

Generate process characterization/technical protocols, reports, stability

summaries and FDA summaries based upon process characterization work

Extensive use of Oracle to generate monthly usage reports and to order

process supplies

Provide technical assistance for projects such as manufacture scale-

up/characterization batches to establish critical operating parameters for

commercial production

Revise and update Production and Commercial scale batch records when

appropriate

Monitor process validation batches and provide assistance where necessary

Participate in various manufacturing process and Quality Assurance

investigations

Serves on assigned teams such as a new product launch performing activities

including monitoring ANDA submission progress and batches. Also, provides

Process Engineering feedback in support of product process scale-up and

validation.

Identify and implement manufacturing process improvements

Evaluate and qualify alternate APIs and manufacturing equipment

Assist in maintaining regulatory compliance and a safe work environment

within the function. Performs other duties as assigned or required by

business needs

SBLI USA., Newark, New Jersey 2005 - 2006

QA Analyst Consultant

0. Prepare and execute new and modified applications/systems across

multiple computing environments including AS400, QuickTest Pro and CRM.

0. Execute manual testing of new or modified applications, systems and

documentation.

0. Involved in the design, development and maintenance of effective testing

plans, test cases and test scenarios using Business Requirements

documentation.

0. Participate in the review of QA procedures and processes and the

development of QA metrics for assessing the quality of delivered

application software or systems

0. Facilitate the analysis, development and maintenance of new or revised

QA documentation.

0. Maintaining detailed error tracking and reporting via quickbase

Organon Inc., West Orange, New Jersey 2002 - 2005

ERP Documentation Analyst / Assistant Project Coordinator (2002 - 2005)

0. Assist in all aspects of project lifecycle to achieve compliance, from

initiation to full compliance.

0. Examine regulations and existing systemic procedures, identify major and

marginal project objectives, formulate viable business and technical

solutions, and translate into design specifications.

0. Organize project team meetings and follow up on action points.

0. Update Project Manager and executive leadership on progression and

developments.

0. Author User Requirement Specifications, training manuals, quick

reference guides, and presentations.

0. Develop, implement, and update work instructions and project plans.

0. Brainstorm new procedures and strategies to optimize the system.

0. Maintain intranet site dedicated to the project and application.

0. Enabled the execution of critical business processes by loading data

into fields for setup of JD Edwards software.

0. Compiled, categorized and constructed digital hierarchy of collections

and content units.

0. Revised and executed several thousand test scripts and scenarios in

developmental and staging environments.

0. Created, reviewed, and revised batch records and compiled key measure

data for KPI reports.

0. Coordinated inter-departmental meetings to address issues and obtain

document approvals within deadlines; meetings included Quality Control,

Quality Assurance, Regulatory Affairs, Validation and Production.

0. Updated master batch records and oversaw documents in change control.

0. Trained and supported end users of Microsoft Word, Excel and Access, and

Documentum.

Genzyme Biosurgery, Ridgefield, New Jersey 1998 - 2002

Quality Assurance Inspector (1998 - 2002)

0. Ensured cGMP compliance in all areas and updated procedures accordingly.

0. Investigated and reported on non-conformance and quality issues;

identified root causes.

0. Inspected and sampled all components and raw materials; audited clean

rooms.

0. Conducted line inspections and packaging audits; maintained label

control and verified compliance.

0. Established expiration dates for intermediate and final product based on

test data.

EDUCATION

Columbia Southern University Bergen Community College

Bachelor of Science, Project Management, Associate of Applied Science,

Management, 2004 1998

Cum Laude Honors, Dean's List

TECHNICAL SKILLS & TRAINING

Software:

MS Word, Access and Excel; Sytline 6.0; JD Edwards OneWorld; Oracle;

Content Builder; Documentum; Solution Modeler, AS400, Quicktest Pro,

Quickbase, StatGraphics, LIMS, Trackwise and CAPA reporting

Training:

JD Edwards: Common Foundations; Defining Items and Supplies; Product Data

Management; Shop Floor Fundamentals; Warehouse Management

Certifications: Project Management (Villanova University, 2005); Clean Room

technique

Other: Microbiological monitoring: slit-to-agar, contact plates, swabs;

equipment sterilization by steam autoclaving; aseptic processing;

validation of class 100 clean room

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