MISAN L. BEZI-RICHARDSON

*** ******* ******, **********, ** 17554

717-***-**** (H) adnznz@r.postjobfree.com 717-***-**** (M)

SUMMARY OF QUALIFICATIONS

Scientist and Quality Control professional offering a unique blend of skills and 15 + years combined technical and sales experience in pharmaceutical manufacturing, analytical services and retail. Hold Bachelor of Science in Chemistry with expertise in chemical analysis, instrumentation and data review. Accustomed to working in a highly regulated environment (cGMP, FDA and GLP) that demands strong organizational skills, multi-tasking abilities, and attention to detail. Personable and outgoing, willing and able to adapt or assimilate to changing environment, able to cultivate and maintain effective working relationships with both internal and external customers. Serve as a role model for positive leadership.

TECHNICAL SKILLS & EXPERIENCE

West, Exton, PA 2004 - 2019

Scientist – Analytical Services

Perform chemical analysis of raw materials, stability and finished products on the GC, pH meter, DSC, TGA, moisture analyzer, Sedigraph, ICP and UV. Ensure that all analyses are in compliance with all cGMP, West methods, client protocols and SOPs. Utilize USP, EP, wet chemistry, protocols and in-house work instructions.

Maintain, calibrate or perform verification when applicable to laboratory equipment, including: GC, balances, pH meter, DSC, TGA, moisture analyzer, Sedigraph, ICP and UV.

Meet individual and departmental goals as required. That is ensuring that 98% of all assigned projects or raw material testing are completed within the due dates or required turnaround times.

Ensure that all assigned raw materials or finished goods designated as rushes for continuous plant support are completed within the required turnaround times.

Perform data review of maintenance and usage logs of instruments.

Responsible for initiating testing, collection of data and writing reports for new, alternate and replacement raw materials evaluations. Ensured that these projects were completed and forwarded for final review in a timely manner.

Interact with internal and external clients as needed.

Prepare work instructions, SOPs and qualification documentation.

Document testing data in clear concise manner to ensure timely release of raw materials, finished

products and stability and future data retrieval.

Coordinated and assisted with special projects including: LIMS scripts execution and updates of specifications for endotoxin test for WESTAR products and in-house test methods.

Coordinated and managed database inventory for over 30 reference standards for laboratory group.

Updated the master list for all products requiring toxicology testing.

Initiated and prepared all necessary documentation and samples still needing toxicology testing by outside contractors.

Write and execute raw material method validation protocols

Write raw material method validation reports.

Perform lab investigations, OOS, OOT, deviations and CAPA as required.

Willingness to learn and apply new analytical techniques.

Train and certify analysts as appropriate.

Keep current with new analytical technology.

MISAN L. BEZI-RICHARDSON

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Wyeth, Marietta, PA 1998 – 2004

Associate Quality Specialist – QC Chemistry Department

Perform chemical analysis of raw materials, in process, stability, water samples, and finished products to ensure specifications are in compliance with all cGMP and SOPs that direct manufacture of

Pharmaceutical products. Utilize USP, EP, wet chemistry and in-house test methods. Perform data review. Perform trending using qualified system.

Maintain and calibrate laboratory equipment, including: GC, HPLC, IR, UV-VIS, AA, balances, pH meter, conductivity meter, polarimeter and osmometer.

Assist in delivering on-the-job training to newly hired QC Analysts. Serve as liaison and point of contact between Chemistry and Purchasing Department for ordering chemicals, reagents and office supplies. Cultivate relationships between external vendors and the department in processing special orders and tracking order status.

Document testing data in clear concise manner to ensure timely release of raw materials, finished

products, water samples, in process and stability and future data retrieval.

Review data from testing, validation protocols, instrument calibration, and other documents attaining 95% error free record keeping.

Perform final disposition of assay order reports to appropriate departments or QA, ensuring timely management approval with a two-week turnaround on 90% of assay orders.

Process all necessary documentation needed to send raw materials to outside testing laboratories to ensure timely completion of test requirements.

Schedule and initiate all necessary documentation needed for calibration, service and preventative maintenance of equipment by outside contractors.

Maintain accurate inventory and record keeping of items purchased and received so as to avoid duplicates or rush orders thereby saving between 5 – 15% for department.

Coordinated and managed database inventory of over 350 reagents, chemicals and reference standards for department.

EDUCATION & TECHNICAL TRAINING

Bachelor of Science, Chemistry, Wright State University, Dayton, OH

LC Resources - HPLC Troubleshooting and Diagnostics, Lionville, PA

Restek Corporation - Comprehensive GC Training Seminar, West Chester, PA

Cause Mapping – Effective Root Cause Analysis, Lionville, PA

Lean Initiative – Lionville, PA

Qualified Level II Trainer (One on One)

Restek Corporation Chromatography Seminar, Elizabethtown, PA

Dionex - HPLC Seminar, Malvern, PA

Microsoft Word, Excel, Access, Internet, E-mail, Novell GroupWise, LIMS, Empower, Millennium, Balance Transfer, SAP, Microsoft Outlook.

DSC and TGA Training Courses – TA Instruments, Delaware

PRIOR EXPERIENCE

Customer Service Representative, Samsonite Company Stores, Lancaster, PA 1997 – 1999

Cashier, Meijer Inc., Dayton, OH 1991 - 1996

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