Quality Assurance Control

Melissa Haywood *** High Street, McColl, South Carolina

843-***-**** 843-***-**** cell

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

Objective Seeking a challenging and responsible position where my experience in gas chromatography and other analytical techniques will be utilized in a Supervisory role.

Qualification Summary More than 7 years working in a manufacturing support laboratory. Familiar with compliance requirements within cGMP, safety and regulatory environments. Operational knowledge of analytical instrumentation like GC, FTIR, UV-VIS, HPLC equipment, and data stations. Extremely solid analytical laboratory skills in addition to microscopy skills.

Education

Bachelor of Science in Biology/Concentration in Zoology

University of North Carolina at Pembroke, Pembroke, North Carolina, 1997

Work

Experience Chemist

January 2011- Present Hospira

Rocky Mount, NC

• Performs analysis of raw materials, in-process, and finished samples via HPLC, GC, FTIR, or wet chemistry techniques

• Following SOPS in a GMP environment

• Performing stability testing protocols

• Investigating analytical problems

• Preparing accurate documentation

• Troubleshooting equipment

• Preparing laboratory media

• Using Chemstation/Empower 2 software programs

Senior Technician

January 2004 – January 2011 QualPak, LLC

Laurinburg, North Carolina

• Assists in the development and execution of qualification protocols including Installation, Operational, and Performance Qualifications for new and/or modified equipment

• Knowledgeable of instrumentation upgrades using processes directed under the Management of Change procedure/guidelines

• Interprets data and adheres to strict guidelines on documentation when recording data and reporting scientific results

• Receives and logs raw materials and finished goods samples into laboratory, and performs Quality Control tests as specified by written Standard Operating Procedures

• Performs daily and monthly calibrations and functional testing as required for various laboratory equipment including analytical balance, ph meter, viscometer, FTIR ,GC and HPLC

• Performs routine analyses on ethanol based products using the gas chromatograph

• Utilizes cGMP to perform, receive, inspect, disposition and release raw materials

• Performs analyses on raw materials utilizing FTIR, LICO meter, UV VIS, Refractometer and other equipment to achieve accurate test results to determine the acceptance / rejection of the raw materials

• Measures, records and reports dimensional, functional and visual attributes per internally specified requirements on incoming components utilizing digital calipers and magnamike utilizing ANSI standards

• 6.5 years experience of utilizing aseptic technique performing microbial tasks including: sample collection, dilution, filtration, streaking, gram staining, and identifying organisms

• Performs inspection, release and quarantine of components including but not limited to: chemical raw materials, packaging components and finished goods utilizing ANSI standards

• Responsible for laboratory inventory, purchasing, and receipt from multiple suppliers

• Lead the effort to contract some calibrations / certifications with outside vendors to establish new equipment requirements

• Performs investigations and drafting of deviations for Out-of-Specification (OOS) and Out-of-Tolerance (OOT) materials and processes within the laboratory and/or facility as required.

• Creates and maintains Standard Operating Procedures (SOPs) and Work Instructions (WIS) for a GMP laboratory and facility

• Responsible for performing monthly retain checks on finished good products and/or as requested by Quality Assurance

• Performs monthly requalifications on raw materials including microbial testing

• Serves on the company Safety committee, where responsibilities included implementing practices within the facility that promoted safety as well as monthly safety audits

• Demonstrates the ability to work alone or with others as required on various tasks

• Certified fork lift operator

Air- Jet Spinner

January 1998 – November 2003 Springs Industries

Laurel Hill, North Carolina

• Operated Air-Jet Spinning Frames which are used in manufacturing of yarn

• Responsible for inspecting product for defects

• Notified maintenance personnel during equipment failures and malfunctions

• Developed ability to fix minor problems with the operating equipment

• Recognized as a trainer for other machine operators

Computer Experiences • Demonstrated proficiency with Microsoft Windows 2007, Word, Excel, and Outlook

• Knowledgeable in the use of Microsoft PowerPoint and Access

• Demonstrated proficiency with AS-400 Material Inventory System to transfer product

References Personal and Professional references are available upon request.

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