Quality Professional

BONITA MCCLAIN WILLIAMS

**** * ******* ****

Raleigh, NC 27604

252-***-**** (cell)

919-***-**** (home)

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

Summary:

Ten plus years experience in a research, GMP and GLP environment including QA/QC compliance, data analysis, data management systems and chemical testing; operations of analytical test equipment; SOP writing and revision; Change control document management; Management of controlled substances; Skilled in defining complex issues and processes, collecting and organizing relevant data, establishing facts and drawing valid conclusions while working with instrument-generated raw data and data management systems

EDUCATION

BS-Chemistry - North Carolina Wesleyan College, Rocky Mount, NC – May 1987

Level I Certificate (training in progress) Clinical Trial Research Associate Durham Technical Community College, Durham, NC

EXPERIENCE

On Assignment-Lab Support/QualPak LLC, Laurinburg, NC Nov 09 to September 11

QA TECHNICIAN

• Reviewed batch records to verify that all cGMP requirements and quality standards were met before releasing components and chemical materials for use and performed final review of final finished good documentation prior to releasing products into marketplace using electronic batch release

• Wrote new SOPs and routed for approval, as well as served as Subject Matter Expert and edited or revised previous versions of SOPs

• Created customer and international certificates of analysis and compliance/manufacture

• Provided yearly company GMP training

• Initiated deviation process when noted during document review and follow-up on associated deviations with necessary personnel to assure appropriate documentation had been completed

• Assess suspect quality components and finished goods to determine final disposition

• Assembled completed manufacturing batch documentation, including Quality Control data, Deviation Summaries, etc.

• Provided investigative support to areas of operations which are impacted by FDA regulations and guidelines.

• Participated in facility or document inspections by customers or FDA

• Verified batch record documentation to ensure that documentation is complete, accurate and prepared in a timely manner

Kelly Scientific Greensboro, NC Jan 08 to Jan 09

CHEMIST

• Evaluated products for chemical manufacturing company and medical device company

MPI Research, Inc. State College, PA April 07 to Nov 07

QA RESEARCH AUDITOR

• Performed independent assessments of protocols, laboratory procedures, data, facilities, subcontractors/vendors and reports, to determine the level of compliance with applicable domestic and foreign Good Laboratory Practice Regulations, (GLPs), Standard Operating Procedures (SOPs) and/or study Protocols.

• Prepared accurate, concise and clear written reports of actual and perceived deviations from GLPs, SOPs, and protocols for submission to Study Directors and management for corrective action and review.

• Coordinated and conducted audits and inspections to ensure regulatory quality compliance by performing the following duties: Conduct comprehensive GLP investigatory, routine and follow-up audits of internal operations. Audit activities included initiation and execution of the audit, generation of the final report, approval of corrective actions, and closure of follow-up activities.

• Provided support to other audit areas, as required.

• Maintained master internal and external audit schedules and quality audit files for regulatory activities.

• Supported the Quality Program to ensure effective quality assurance auditing of interim/final reports, protocols and amendments for regulatory agency submission, and other similar documents against original and/or raw data.

Leiner Health Products, Wilson, NC Jul 05 to Dec 05

CHEMIST

• Performed routine and non-routine quality control testing of raw materials, finished product, and stability testing within the framework of site policies, departmental procedures, and cGMP regulations.

• Prepared solutions and standardized test solutions when applicable.

• Troubleshooting equipment and analytical problems, and initiating and/or implementing changes in controlled documents, via change control.

• Initiated and completed OOS investigations for product.

Alion Science and Technology, Newport Chemical Depot Facility (NECDF), Newport, IN Dec 03 to Mar 05

QA/QC INSPECTOR

• Reviewed QC reports to include analysis of statistical data prior to submission to DHHS (Department of Health and Human Services) and CDC.

• Assisted in the coordination of onsite audits performed by regulatory agencies and site contractors -QA Department; provided responses and implemented changes to audit findings as appropriate

• Wrote, reviewed, and updated QA/QC procedures.

• Worked with analytical and monitoring personnel to ensure that all laboratory and environmental monitoring activities were conducted in compliance with the NECDF SOPs, NECDF LQCP and Army Regulations.

• Ensured that all deviations and discrepancy reports were properly addressed and documented.

• Performed surveillances, inspections, and audits to assess and ensure compliance with NECDF SOPs, NECDF LQCP and Army Regulations

North Carolina Biotechnology Center, Research Triangle Park, NC Aug 01 to Jan 03

INDUSTRIAL TRAINING CONSULTANT

• Developed specifications for training program focused on equipment and laboratory operations.

• Assisted in the development and implementation of training programs in support of the pharmaceutical, chemical and bioprocess manufacturing industries.

• Researched, reviewed materials and created training materials.

• Coordinated training schedules and delivered training to Process Technicians in conjunction with the North Carolina Community College System

Biovail Technologies, Ltd, Chantilly, VA Jun 00 to Aug 01

FORMULATIONS SUPPORT CHEMIST

• Recorded and reported data accurately and in compliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP.

• Set up, calibrated, operated and performed maintenance of laboratory test equipment, including but not limited to HPLC, dissolution baths and UV systems.

• Performed physical testing of formulation products, finished products and stability products (sieve analysis, friability, moisture determinations) and recorded and documented all results for formulation investigations.

Abbott Laboratories, Hospital Products Division, Rocky Mount, NC Oct 96 to Jul 99

SENIOR QUALITY ASSURANCE SPECIALIST

• Responsible for auditing laboratory work order packages for manufactured pharmaceutical products, technical service requests and engineering change requests for compliance with standard test methods and ensuring compliance with GMP and summarizing data and results in accordance with company and FDA regulations prior to their inclusion in product batch records.

• Wrote protocols for, performed and wrote final reports for analytical methods transfer and validation.

• Supervised technicians in R2 laboratory and assigned and audited analyst data and reports.

• Monitored controlled drug logbooks and prepared deviations.

• Responsible for updating and evaluating testing forms as needed.

• Responsible for initiating OOS investigations when necessary.

• Performed routine and non-routine analysis of raw, in-process and final product materials as needed in accordance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP. with procedures including, but not limited to USP testing methods, Concentration assays, GC, Titrations, Distillations, Extractions, Karl Fischer, UV/VIS Spectroscopy, IR and FTIR Spectroscopy, Polarimetry, HPLC, and Atomic Absorption Spectroscopy and entering that data into LIMS

TRAINING

North Carolina Central University, Durham, North Carolina, Graduate Courses in Educational Administration and Supervision

Attended DNA and Biotechnology Methodologies workshop sponsored by NIH in Bethesda, MD

Attended specialized training at Chemical Demilitarization Training Facility at Aberdeen Proving Grounds in Edgewood, MD with courses including Laboratory Essentials Training, Process Residue Analysis, DAAMS GC Operation, Sample Collection Training, MINICAMS Operator Training, Laboratory Quality Control Training

Attended workshops in Project Management and Time Management

Successfully completed written examination and continuous evaluation for the 36-hour RAB Accredited Lead Auditor course for ISO 9001:2000

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