Quality or Project Management Postions Resume
|Desired Industry: Biotech
|Desired Job Location: Roanoke, Virginia
||Date Posted: 6/30/2009
|Type of Position: Part-Time Permanent
||Availability Date: 09/01/2009
|Desired Wage: 95000
||U.S. Work Authorization: Yes
|Job Level: Management (Manager, Director)
||Willing to Travel: Yes, Less Than 25%
|Highest Degree Attained: Bachelors
||Willing to Relocate: No
To obtain a management position that will utilize my project management, quality assurance, regulatory and operations experience to enhance business performance and growth.
Hospira, Inc -Rocky Mount, NC
New Products Project Manager & Sr. Quality Engineer May 2004 - Present
Responsible for providing project management and quality assurance leadership to support new product launches and manufacturing. Specific accountabilities include:
• Leading project teams to develop manufacturing support documentation for submissions and annual report
• Develop, review and approve analytical methods, scientific reports and validation protocols to assure compliance with government, regulatory and cGMP requirements.
• Manage clinical, stability and first lot to stock manufacturing runs.
• Facilitate communications meetings with all functional areas to assure that project timelines and deliverables are met.
• Conduct audits of validation protocols, analytical reports and batch records which support formal regulatory filings including NDA and ANDA CBE30 and Prior Approval Supplements.
Abbott Laboratories Abbott Park, IL
Sr. Division Quality Assurance Engineer - Hospital Products Division July 2003 - May 2004
Responsible for the standardization of validation policies and procedures for fourteen manufacturing sites worldwide. Primary focus areas include parenteral drug processes, production and laboratory equipment, and computer software and control systems. Specific accountabilities include:
• Approver and change control manager for validation protocols and procedures that have global compliance and quality impact.
• Audit presenter during internal, 3rd party and FDA audits to review validation program.
• Audit, conduct training and participate in validation related investigations to assure adherence to industry and divisional requirements.
Manufacturing Section Manager October 2000 - July 2003
Special Products Division
Responsible for the production, quality systems and $6.5 million operating budget for R&D, clinical, and third party products. Manage a staff of seven direct reports and twenty-one technicians. Specific accomplishments included:
• Acquired two new manufacturing contracts with annual profits of $1.8 million through coordinating activities between sales, development, and regulatory compliance.
• Improved the operating variance by $300,000 as a result of driving projects that improved yield and reduced raw material and labor cost.
• Consistently met quality, production schedule and delivery targets through the management, tracking, and implementation of investigation reports with effective corrective and preventive actions.
• Set performance objectives and goals for direct reports. In addition, provided career coaching,, training, and accomplishment recognitions to motivate, inspire and develop personnel.
• Managed the CAPA investigation system in the facility to assure timely and accurate responses to quality and operations related events.
New Products Validation Engineer August 1999 - October 2000
Hospital Products Division
Responsible for executing process and equipment validation protocols new products in order to meet contract agreements and regulatory submission targets. Accomplishments include:
• Implemented a new validation summary reports documented used by regulatory, quality assurance and program management to document status of validation and submission of new products.
PPG Industries - Shelby, NC
Sr. Engineering Associate- Reinforced Fiber Glass Intermediate January 1996 - July 1999
Responsible for the operation, quality and $8.0 million operating budget performance of two production areas with a direct staff of 120 production and maintenance employees. Accomplishments include:
• Saved $250,000 on the operating budget by reducing resin usage and designing a resin recycle process that contained a computer program that generated optimal settings for critical control parameters.
• Provided on-site technical support to customers by serving as the manufacturing representative on customer and supplier teams, which consisted of marketing, development, and operations personnel.
DuPont – Old Hickory , TN
Process Engineer, ISO9000 Quality Engineer & First Line Supervisor May 1991 - July 1999
Proctor and Gamble – Oglethorpe, GA
Scholarship and Internship Engineering August 1986 – May 1991
Bachelor of Science, Chemical Engineering May 1991
The University of Tennessee- Knoxville, TN
Delta Sigma Theta Sorority
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