Project Manager

LINDA L. SANIEWSKI

www.linkedin.com/in/lindasaniewski

864-***-**** *****.*********@*****.***

SUMMARY OF QUALIFICATIONS

Quality Manager with extensive experience in global pharmaceutical manufacturing. Recognized for ability to plan, design, and implement global departmental change through cost reduction, improvement in testing methods, and communication. Skilled in development of organizational objectives and long-range goals. Proven ability to provide technical guidance in reviewing analytical methodology, assuring compliance with cGMP and global regulatory guidelines, and initiating Quality Control laboratory process improvements.

PROFESSIONAL EXPERIENCE

CAPSUGEL (Division of Pfizer), Greenwood, SC 2001 – 2010

Global Stability Program Coordinator 2007 – 2010

Coordinated operations with Quality Manager and global affiliates and managed one direct report who conducted testing according to cGMP, ISO, and global and domestic regulatory guidelines. Collaborated with global affiliates to make changes in environmental storage of products and improve packaging of products, and reported results in a timely manner. Proved ongoing integrity of 12 company products using wet chemistry methods obtained from global pharmacopeias for the absence of foreign material as possible contaminants formed during the manufacturing process.

• Initiated directives to reduce costs while improving quality and efficiency and reduce non-value added testing earning a yellow belt in Six Sigma.

• Conducted internal audits and investigations to improve safety and housekeeping standards and reduce costs.

• Developed objectives and long range goals by focusing on needs analysis in lab areas, including training, time and resource management, process improvements, and cost control activities that decreased time needed to set-up parameters for product tests.

• Interacted with Global affiliates regarding receiving, storing, testing, and reporting results through SharePoint Website and Annual Global Stability Report which provided basic and statistical analysis.

Senior Chemist, Chemistry and Stability 2001 – 2007

Performed testing under the Quality Manager and Global Stability Supervisor using HPLC, GC, FTIR, spectroscopy and wet chemistry methods on domestic and global products. Verified raw material and finished goods met USP and other pharmacopeia specifications and reported results to Supervisor in a timely manner.

• Improved use of working papers by converging individual samples of the study into one set of working papers per study that increased visibility of sample results while reducing time by eliminating redundancies.

• Maintained chemical database and laboratory housekeeping on a scheduled frequency.

• HPLC was also used to identify the purity of intermediate and final pharmaceutical synthesized compounds using UV, RI and PDA detectors, method development, identify raw materials involved in excipient manufacturing and by-products from excipient manufacturing and customer complaints. Identify combinatorial and chiral compounds.

• Perkin Elmer GC Clarus 500 using Turbochrome or current Totalchrom software and HP 5880 and HP 5890 for identification of intermediate and final pharmaceutical synthesized compounds and raw materials containing fats and oils.

LINDA L. SANIEWSKI PAGE TWO

PFIZER (Formerly Warner-Lambert), Morris Plains, NJ 1999 – 2001

Reformulations Scientist B

Performed analysis on reformulated pharmaceutical products using HPLC following United States Pharmacopeia Guidelines.

NOVARTIS (Formerly Sandoz), East Hanover, NJ 1981 – 1999

Scientist

Performed Preparative and HPLC, GC and some LC/MS chromatography for Chemists to purify and analyze organic molecules for Research and Development. Collaborated with chemists in development of Gleevek, a pharmaceutical medication to reduce cancer tumors.

COMPUTER SKILLS

• Microsoft Office (Outlook, Word, Excel, PowerPoint), Visio, Access

• Talisco Picture Processing Methods

• Minitab

• NVivo 8

EDUCATION AND PROFESSIONAL DEVELOPMENT

PHD, University of Phoenix Online, 2011

MBA, University of Phoenix Online, 2005

BA, Applied Sciences, William Paterson University, Wayne, NJ

• Method 1 Training for Six Sigma, 2008

• Stability Webinars, International Validation Technology, 2008 – 2010

• Stability Conference, International Validation Technology, 2007

PROFESSIONAL AFFILIATION

Member, American Chemical Society, 1983 – Present

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