Quality Assurance Manager

Jennifer Caldwell **********@*******.*** ? 859-***-****

**** ******** **** ? Lexington, KY 40509

Quality Assurance Manager

Results and detail-oriented Quality Professional with 10 years' experience

in ensuring compliance with current Good Manufacturing Practices (cGMP) in

pharmaceutical manufacturing, packaging and distribution environments.

Achieve fast-track promotions to positions of increased responsibility

based on measurable contributions to operating performance. Demonstrate

high level of initiative and problem-solving skills in complex environments

involving cGMP and development and implementation of Corrective

Action/Preventative Action (CAPA) necessary to ensure product Safety,

Identity, Strength, Purity and Quality (SISPQ). Highly effective

communicator with suppliers, vendors, contractors, customers, and staff of

all departments at production and corporate levels.

Inspections/Audits cGMP Compliance Environmental Monitoring

Vendor/Supplier Relations Root Cause Analysis Product Launch

NDA Review Annual Product Reviews Customer Relations

Batch Records Review & Management CAPA Investigation Reports

Professional Experience

Xanodyne Pharmaceuticals, Newport, KY 2007-Present

Corporate Quality Assurance Associate

Hired to bring quality functions in-house for virtual manufacturer and

distributor of pain management and prenatal vitamin products. Liaise

internally between Operations, Technical Services, Medical Affairs,

Regulatory, Product Development, and Marketing and Sales departments.

Supervise product releases and collaborate with suppliers to ensure smooth

operations between distribution center and market placement. Conduct

supplier audits to ensure compliance with cGMP regulations and internal

standard operating procedures. Review and approve supplier master batch

records, annual product reviews, and deviation and investigation reports.

Key Achievements:

. Defined and implemented batch record review certification program; create

and revise standard operating procedures.

. Played integral role in successful launch of two NDAs and assisted in

compressive product preparation.

. Brought produce release responsibilities in-house, saving significant

costs in consulting fees.

. Aided in establishment of GMP systems, including document control,

supplier audits, investigation/deviation review and approval, and CAPA.

. Effectively respond to customer quality complaints and assist in

facilitating and closing investigations.

Catalent Pharma, formerly Cardinal Health, Winchester, KY 2000-2007

Senior QA GMP Compliance Coordinator (2004-2007)

QA GMP Compliance Auditor (2003-2004)

Quality Assurance Associate (2002-2003)

Quality Assurance Specialist (2000-2002)

Rapidly advanced to senior role to manage increasing audit responsibilities

and provide valued experience in client relations. Prepared and reviewed

audit and inspection documents and entered data and CAPA commitments into

TrackWise electronic database. Organized all formal responses to inspection

reports and performed necessary follow-up and closure procedures. Performed

internal audits and provide CAPA and audit metric information/executive

summaries to site and executive QA management staff. Monitored building

data for temperature, relative humidity, and differential pressure.

Completed physical release for shipment and electronic release of finished

products through ERP system and JD Edwards software. Drafted Level III

laboratory investigation reports and ensured cleanliness of manufacturing

suites and equipment by collecting cleaning validation and environmental

swabs.

Key Achievements:

. Developed manual tracking system in Excel for follow-up and closure of

CAPA from internal and external audits.

. Contributed to creation of CAPA TrackWise module for streamlined,

electronic management.

. Served as customers' first point of contact concerning product issues and

batch records.

Computer Skills

J.D. Edwards OneWorld Database / TrackWise / Active Factory 9.0 /

Documentum / PharmaReady / Abra Suite

Microsoft Office (PowerPoint, Excel, Word, Outlook, Exchange)

Education & Professional Development

BBA, emphasis in Computer Information Systems, Morehead State University,

Morehead, KY

Business Administration Coursework, Murray State University, Murray, KY

International Good Manufacturing Practice Conference, Athens, GA (2005,

2008, 2010)

LSS (Lean Six Sigma) White Belt Training

Community Activities

American Cancer Society - Relay for Life, 2006

Serve the City, 2009-2010

Susan G. Komen - Race for the Cure, 2010

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