Professional Experience

Millstone Medical Outsourcing, LLC Olive Branch, Mississippi

May 2014 to present

Quality Assurance Specialist

Assist the Quality Director in the management of both domestic and foreign non-conformances in order to provide an effective corrective action.

Work in collaboration with other members of the Quality Department to prepare for and host (if needed) internal and external auditors

Assist other members of the Quality Department and facility management team to ensure timely closure of any audit observations

Ensure that corrective action plans are implemented and followed up for effectiveness

Conduct thorough investigations to accurately identify non-conformances and deviations in policies and procedures

Maintain and manage the Quality System for traceability of all non-conformances by assigning issue within two days for immediate investigation and disposition.

Assist with the logging, trouble shooting, investigation and progression of issues with non-conforming product, processes or work in a timely manner.

Review all validations for accuracy and completion (IQ, OQ and PQ)

Ensure that validation protocols are performed and reported according to established guidelines

Ensuring that products conform to established requirements and standards through appropriate audit, inspection, and test activities

Perform physical inspection of products and comparison/assessment to all related documentation within the warehouse as needed

Quality release of finish goods to ensure that it complies with functional, visual and packaging requirements

Technical writing of various documents including but not limited to procedures, protocols, internal assessment reports, audit observation responses, and non-conformance reports, engineering change controls, process flow mapping and PFMEAs

Maintaining an interdependent relationship with all functional areas within the facility and engage in cross-functional collaboration

Familiar with Oracle, ERP, SAP, Agile, and Microsoft Office (Word, Outlook, PowerPoint, and Excel)

Preparing annual reports for Tissue Bank licensing

Advanced knowledge of FDA and ISO 13485:2003 regulations for Tissue Licensing and Medical Devices

Participated in acquiring VAWD accreditation for the facility

Participate in external three FDA and two BSI audits resulting no findings

Participate in State Licensing Agencies, Clients, and Potential Clients

Implement corrective action/preventative actions for non-conformances as well as implementing process improvement s

GlaxoSmithKline, Memphis, Tennessee

October 2007 to July 2014

Lead Chemist

Ensured that the highest quality testing was performed in compliance with FDA and GLI specifications, protocols, cGMP and safety regulations

Performed raw material, intermediate and finish goods testing procedures in accordance to USP, FDA, and SOPs.

Provided a well-developed training program which included both laboratory safety and testing procedures.

Supervised chemist in performing both quantitative and qualitative testing for product release.

Initiated laboratory investigations for all non-conforming products

Analyzed the product by using various instruments for identification (GC, HPLC, IR, UV-VIS, AA, FTIR, Karl Fisher and Autotitrators).

Competent in working with related software package needed to analyze samples (Empower, Microsoft Office, etc.).

Assisted in the validation of products and equipment

Performed technical writing of protocols, SOPs, procedural revisions and training modules

Safety Coordinator for the Quality Department (recording near miss, performing risk assessments, monitoring PPE usage and conducting monthly safety meetings)

Familiar with LIMS, Empower, TurboChrome, Microsoft Word, Excel, Outlook, and PowerPoint

KIK Custom Products Memphis, Tennessee

September 2011 to September 2012

Lead Chemist

Perform various assignments within the Quality Lab to support production to ensure that the highest standards are met by testing raw materials, intermediate and finished goods using a variety of qualitative and quantitative techniques.

Provided supervision, training while managing the work flow to ensure that testing was completed per manufacturing schedule

Analyzed the product by using various instruments for identification (HPLC, IR, UV-VIS, Karl Fisher and Autotitrator).

Competent in working with related software package needed to analyze samples (Empower, Microsoft Office, etc.).

Strong interpersonal and communication skills necessary to interact with internal and external customers.

Complying with company GMP, GLP, and Safety Policies and Procedures.

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Pharmedium /Aerotek Memphis, Tennessee

January 2011 to July 2011

Contract Chemist

Assist in routine testing procedures in accordance to USP, FDA, DEA and SOPs.

Analyzed Schedule I and II USP standards and samples (Hydromorphone HCl, Midazolam, Morphine Sulfate, Ephedrine, Phenylephrine)

Tracking and traceability of the usage of USP Standards for Controlled Substances

Destruction of expired controlled substances

Maintained the chemical inventory list consisting of USP Schedule II standards

Consistently maintaining Good Laboratory Practice (GLP) and Good Manufacturing Practices (GMP)

Buckman Laboratories, Memphis, Tennessee

October 2001 to October 2007

Chemist

Analyze product samples through extensive use of Karl Fisher, Autotitrator, FTIR, UV-VIS, GC, and HPLC on all batches, intermediate and final stages.

Prepared all internal and active standards using manufacturer supplied reference standards.

Prepare and present oral and written analyses of lab results.

Able to measure instrument variations and apply corrections for ensure accuracy and precision of various instruments and measurement tools.

Research and resolve internal and external customer inquiries including generating C of A’s.

Strong knowledge of ISO 9001:2000 and Environmental, Health and Safety Policies and Procedures.

Education

University of Memphis, Memphis, TN

Bachelor of Science, Biology

August 2005

Columbia Southern University, Orange Beach, AL

Bachelor of Science, Occupational Safety and Health-Sum Laude

October 2015

Columbia Southern University, Orange Beach, AL

Masters of Science, Occupational Safety and Health

To be completed by August 2017

Professional Organizations

American Society of Safety Engineers (ASSE)

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