Quality Assurance Manager

Kimberly Nester

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

**** ******* **** *****, **** 3A High Point, NC 27265 Home Phone 336-***-****

Cell Phone 720-***-****

Professional Summary

Performance-driven leader offering 20 plus years of proven ability to develop and direct highly successful departments and groups. Working in regulated environments, such as FDA, and DEA utilizing cGMP's to ensure adherence to quality practices. Knowledge consists extensively of operations and manufacturing, expert at creating and implementing policies and procedures such as: ISO9001-2008 quality systems and registration, SOP's, work instructions and forms. Strong skills in supply chain management, multi facilities, and customer service. Adept at building partnerships and negotiating business contracts. Outstanding presentation, motivation, and communication skills. Master of Science in Business Management and Project Management, with a minor in Pharmaceutical Engineering.

Core-Competencies/Accomplishments

• Responsible for multi-facility operations.

• Effectively manage manufacturing / production process with close attention to budgets, timeframes, quality, and product specifications.

• Develop and implement strategies that increase product awareness, market share and profitability.

• Managed up to 86 direct reports for Pharmaceutical Distribution Operations and Raw Materials Warehouse.

• Created and implemented a Rapid Ship Program for Launching new products.

• Increased dollar amounts from $60 million per/month to $163 million per/month.

• Six Sigma Green Belt Certification through North Carolina State University.

• Decreased Department changeovers saving company $80,000 and over 1000 hours of run time per/year.

• Increased inspection rate by 40% by improving the inspection process.

• Inventory Management; created, implemented, inventory procedures including daily cycle counts, reorder quantities which resulted in a 99.8% inventory average.

• Successfully developed and executed laser rod product site transfer from Washougal, Washington facility to the Boulder, Colorado facility. With machines, processes and production back in process within one week, eliminating zero impact to customers.

Professional Experience

Nov. 2011 - Present Ameritox Greensboro, NC

Director of Operations Support Reporting to Chief Operating Officer

• Review, Manage and Negotiate contracts with operations vendors. Complete ownership of vendor contracts/ Service Level Agreements (SLA) including renewals.

• Established and maintain relationship with Fed-x and UPS, including tracking and continuous improvements projects.

• Established new and support existing metric reports

• Monitor current Operations budget, support COO in develop of budget year over year.

• Manage costs and ensure the teams are meeting the required contribution targets

• Support and direct strategic lab operations projects, including tracking of ROI.

• Internal customer support including training, tracking, metrics, analysis and reporting

• Support field sales teams with supplies

• Collaborate across departments to identify customer gaps and support requests to improve service. Partner with Field Sales to ensure client deliverables and escalations are handled in a timely manner

Kimberly Nester

July 2009 - Nov. 2011 Banner Pharmaceuticals High Point, NC

Post Production Supervisor Reporting to Post Production Manager

• Review Batch Records, Safety, OSHA, SOP, am responsible for the all Work Instruction and departmental Forms, the writing, designing of departmental training program, training and implementation for the Post Production Department of 120 employees, and regulatory FDA and cGMP Training

• Accountable for reports such as non- conformances, summaries, and customer complaints.

• Responsible for in-house product investigations and findings, and communication with all internal departments.

• Accountable for 35 direct reports.

• SAP Super User

• Responsible for all of Post Production Work Instructions and forms, writing, updates, and design.

• Responsible for Department Trackwise system transactions.

Feb. 2008 – April, 2009 Saint-Gobain (Formally Alpine Research Optics) Boulder, CO

Production Manager Reporting to Operations Manager

• Responsible for the following departments: Fabrication, Coating, Quality Control Inspection, Planning, Scheduling, Shipping, and Receiving, with 23 direct reports.

• Performed training, initiated 5S and lean manufacturing programs throughout departments.

• Implemented continuous process improvements to streamline manufacturing and shorten production time on the top 10 products.

• Developed, implemented and trained on procedures throughout all departments for ISO 9001-2008 registration within 3 month time frame. (Started in January 2009 Company registered March 2009).

Jan 2007 –Dec. 2007 Attended and Graduated from Colorado Technical University, Colorado Springs, Colorado

Bachelor of Science in Business Management, Graduated Magna Cum Laude.

May 2006 – Dec. 2006 Barr Laboratories Cincinnati, OH

Packaging Supervisor Reporting to Packaging Director

• Trained and supervised 26 Packaging Operators while providing daily direction in order to achieve department objectives.

• Develop Packaging plans and measure team performance against goals.

• Assign resources to meet the Packaging schedule on a day-to-day basis.

• Review and audit Packaging records and documentation.

• Develop and implement initiatives to improve quality, cleanliness, safety, and productivity, and to reduce costs.

• Trained and adhered to regulatory requirements (FDA, cGMP, SOP), for pharmaceutical Packaging Operations, as well as SAP transactions.

July 2005 – May 2006 Colonial Carton Company Clayton, NC

Quality Assurance Manager Reporting to President/CEO

• Responsible for GMP compliance and training.

• Work directly with management team to constantly improve quality and production.

• Develop and modify production processes and documentation to improve product quality.

• Conduct walk-throughs of the facility to ensure all cGMP and SOP standards are met and maintained.

• Responsible for QA final inspections, calibrations and safety programs.

• Reviewed and approved all production batch records.

• Provide reports to management on the quality of performance of operations.

• Responsible for ISO, OSHA, Internal and Supplier audits.

Dec. 2000 – July 2005 Sandoz Pharmaceuticals Broomfield, CO

Regulatory Compliance Specialist Reporting to Supervisor of In-Process Quality Assurance

Kimberly Nester

• Designed and implemented internal audits for 10 departments.

• Participates in formal audits focusing on specific functional areas. Prepare reports and document

Findings.

• Responsible for raw material review and release using SAP.

• Managed Quality process improvement projects. Compile/Summarize regulatory standards/guidelines to

Provide training for continual improvement of the knowledge base of our group.

• Work directly with Operations Management to analyze metrics and provide corrective

Action plans for issues observed in walkthroughs, audits or deviations.

• Responsible for providing quality assurance support to Manufacturing Operational areas.

• Designed and developed a Training Manual for Quality Assurance Department.

• Responsible for reviewing and signing off for micro reports and equipment.

Packaging Supervisor Reporting to Packaging Manager

• Responsible for managing the daily operations of 4 Packaging Lines, with 4 Leads and 20 employees.

• Responsible for a weekly output of approximately 12 million units per/week.

• Project Manager for communications implementation which increased productivity in the Packaging Department by 50%.

• Reviewed Batch Records, Safety, OSHA, SOP, SAP and cGMP Training, communication with QA,

reports such as non- conformances and summaries, customer complaints.

• Ability to Initiate and implement change, changes in process: Incentives being introduced to further

Productivity. Daily shift meetings before and after the shift to maintain open communication

Between the shifts and on the floor.

Distribution Supervisor Reporting to Distribution Manager and Director

• Responsible for managing operations of a four-shift Distribution Center with 4 Leads and 76 employees.

• Created and implemented Tech. Program and Training for all Distribution employees adhering to all FDA, DEA, SOP and cGMP regulations.

• Increased productivity from 100,000-150,000 units to 275,000-325,000 units per day.

• Increased dollar amounts from $60 Million per/month to $163 Million per month.

• In charge of all DEA Cage and DEA Vault operations.

• Developed hiring, training in SOP’s, SAP, cGMP’s and motivational programs to enhance employee success and value, within company expectations and standards.

• Created and implemented the Rapid Ship Program.

1999- 2000 Glaxo Wellcome Inc. Research Triangle Park, NC

Clinical Supply Specialist (Contracted through Kelly Temp. Agency)

• Employed in the Research and Development Department, creating and labeling Clinical Supplies for investigation drug studies per/cGMP regulations.

• Conducted my internship with Glaxo Wellcome in 1999. Upon graduation was requested to join their organization. (Supervisor Brian Neptune).

Education North Carolina State University, June 2011, Raleigh, North Carolina.

Six Sigma Green Belt Certification.

Colorado Technical University, December 2010 Colorado Springs, CO.

Master of Science Degree in Project Management.

Colorado Technical University, November 2009 Colorado Springs, CO.

Master of Science Degree in Business Management.

Colorado Technical University, December 2007 Colorado Springs, CO.

Bachelors of Science Degree in Business Management. Graduated Magna Cum Laude

Wake Technical Community College, May 2000, Raleigh, NC.

Associate of Science Degree in Pharmaceutical Engineering.

Kimberly Nester

Certifications & Completed the CIRM/APICS program. Winner of the Best Class Speaker Award from Dale Carnegie

Accomplishments Undergraduate certifications From Colorado Technical University in Basics of Accounting and Finance,

Business Fundamentals, Business in the Global Environment, Human Resource Development, Management

Essentials, Organizational Systems, Improvement, Project Planning, Sales and Marketing.

Graduate certifications from Colorado Technical University in Change Management, IT and

Business Transformation. Certified Six Sigma Red Belt from North Carolina State University 1/5/2011. Certified Six Sigma Green Belt from North Carolina State University 6/20/2011.

Computer Worked with the following programs: SAP (Super user), Trackwise, Kronos, Lims Labware, PeopleSoft,

Skills Infinity QS, Excel, Microsoft Word, Power Point, Gelco, Foldware, Vista, AS/400 and GXPharm.

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