Administrative Assistant Quality

EXECUTIVE SUMMARY

Quality focused professional with over 22+ years of experience in general business operations, project management, and financial administration. Extensive experience in operations and manufacturing management. Committed to driving business success by implementing superior customer service standards, effectively training individuals and teams. Record of improving efficiency, productivity, and profitability through automation and process improvement. Outstanding interpersonal and analytical skills.

CORE COMPETENCIES

Strategic Planning

Quality Control

Manufacturing Automation

Process Improvement

Client Relations

Project Leadership

Process Improvement

Training and Development

Proficient in File Surf, SAP, LIMS, Gelco, ProUnlimited, MS Visio, Ariba, Adobe PageMaker 6.5, Microsoft Suite, & Lotus 1-2-3, TrackWise

Data Entry 10,000+KP

PROFESSIONAL EXPERIENCE

NOVARTIS (formerly SANDOZ)

Wilson, NC

Analyst I, Quality Business Systems/Stability Apr. 2017-January 2021

Provide ongoing electronic support and maintenance activities such as product builds/ modifications, LIMS printer maintenance, LIMS folders builds, ad hoc queries, crystal report builds/modifications, electronic data reporting, interface maintenance, etc.

Assess change control for changes affecting electronic systems. Conducts routine checks for login from SAP to ensure all samples are accounted for and discrepancies are resolved by manual SAP/electronic systems entry if necessary in a timely fashion.

Responsible for building tests/ calculations in electronic systems and verifying accuracy through executed qualification protocols. Generates and updates electronic/standard forms.

Author and maintain appropriate SOPs relating to electronic systems as required (General use, activities, security, etc.) Work on Quality information system projects.

Maintain detailed descriptions of Quality business and user needs, as well as documentation of steps in resolution process. For “standalone, non- network applications,” maintain vendor relationships for error resolution, and assist with the development of a new program.

Generate stability protocols and Post Approval Stability Commitments.

Generate reports for Regulatory Affairs Annual Reporting

Provide preliminary recommendations for quality issues identified and the appropriateness of action(s) taken for resolution in relation to stability areas.

Interact with other departments to resolve documentation issues. (e.g. Operation, MS&T, FP, IQC and RM).

Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

LIMS Technical Support Analyst Feb. 2010 – March 2017

Administered LIMS user training per the approved user’s manuals.

Provided training updates based on trends and data observed in the system (such as closing lots or reporting requirements for individual types of samples).

Assisted users with issues regarding performing functions in LIMS, clarifying business processes relating to LIMS, and troubleshooting LIMS Zebra printer issues.

Assisted in resetting and acquiring passwords and access for users.

Met all project timeline goals. Met final project goals which have been assigned.

Developed and use LIMS queries/reports to generate metrics and eliminate Control Center Status Sheets.

Control Center Administrator Sept. 2009 – Jan. 2010

Provided support to the Quality Control Laboratory. Prepared Kits for the Chemists so that they could perform tests on different products.

Ordered office supplies and Lab supplies. Entered samples into our LIMS database system.

EON LABS (Now SANDOZ)

Wilson, NC

Quality Control Administrative Assistant I Oct. 2002- Aug. 2009

Provided operational/management and clerical support to the Director of Quality Control. Monitor office supplies. Composed and type letters, memorandums, reports, and other printed matter. Proof read and edit letters, memorandums, and reports.

RELATED PROFESSIONAL EXPERIENCE

SAINT AUGUSTINE’S COLLEGE

Raleigh, NC

Office Manager/Administrative Assistant Aug. 2000- Oct. 2002

Gift Records Clerk/Administrative Assistant/Data Entry Operator Sept.1999 - Aug. 2000

EDUCATION

American InterContinental University (AIU) Chicago, IL 2014

Master’s in Business Management, Specialization in Accounting

American InterContinental University Chicago, IL 2013

Bachelor’s in Business Management

3.61 GPA

East Coast Polytechnic Institute (ECPI) Raleigh, NC 1996

Medical Computer Specialist

3.7 GPA Member of National Honor Society Academic Excellence & Attendance Awards

Thomas Health Care Institute Raleigh, NC 1993

Phlebotomy

4.0 GPA Member of National Honor Society

Wilson Technical Community College Wilson, NC 1989

Associate’s in Business Administration

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