Quality Assurance Management

Nicole Chaplin Murray

** ********** *****

Clayton, NC 27527

919-***-**** / ****************@*****.***

SUMMARY OF QUALIFICATIONS

Quality-minded, self-motivated, college- and military-educated pharmaceutical professional with nearly 10 years experience at three global pharmaceutical companies. Proficient in all aspects of Good Manufacturing Practices (GMPs), including the batch release process, document control, investigations, process improvements, and inventory control. Knowledgeable in national and international regulatory requirements. Excellent communicator with proven organizational management of multiple projects, objectives, and deadlines.

SELECTED ACHIEVEMENTS

Applied Six Sigma (DMAIC) methodologies to improve batch production record (BPR) approval cycle times to less than 24 hours. Chaired continuous improvement project to optimize inventory management system for access to greater than 1,000 dedicated spare parts. Achieved SAP Super User status within one month. Obtained Internal Auditor certification (online).

PROFESSIONAL EXPERIENCE

Supported process validations, qualifications, calibrations, experimental, pilot, and scale-up activities according to standard operating procedures (SOPs), US FDA and international GMPs, corporate standards, and applicable national and international regulations. Authored, revised, and reviewed BPRs, SOPs, product specifications, and other relevant quality system documents as outlined in Quality Assurance (QA) programs. Strong communication and collaborative team skills demonstrated by participation on numerous Material Review Boards (MRBs) and cross-functional teams. Participated in development, implementation, maintenance, and continuous improvement projects in GMP environments, including initiating and reporting process deviations, working with management to assign responsibilities, ensuring problems solved within established timeframes, and preparing summary reports and spreadsheets. Completed Environmental Monitoring non-conformity reports, including root cause analysis and corrective action/preventive action (CAPA) plans. Reviewed and monitored computer trends and electronic data to support investigation of issues leading to potential downtime of pharmaceutical operations. Working knowledge of Microsoft Office applications (i.e. Word, Excel, and PowerPoint), SAP, Supervisory Control and Data Acquisition (SCADA) Systems, and scanning systems.

EMPLOYMENT HISTORY

Aseptic Process Specialist, Talecris Biotherapeutics, Clayton, NC, 2010 – Present

Formulation Process Specialist, Hospira, Inc., Clayton, NC, 2008 – 2008

Flexpen System Technician, Novo Nordisk Pharmaceutical Industries, Inc. (NNPII), Clayton, NC, 2007 – 2007

Batch Release Specialist, NNPII, Clayton, NC, 2004 – 2007

Maintenance Administrator, NNPII, Clayton, NC, 2002 – 2004

Sergeant (E-5), US Air Force, Seymour Johnson Air Force Base, NC, 1997 – 2001

EDUCATION

Bachelor of Business Administration, Strayer University, Garner, NC (2010)

Logistics Management Honor Certificate, Logistics Management Technical School, Lackland AFB, TX (1997)

CERTIFICATIONS

Internal Auditor, Quality Gurus (online) (2010)

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