Alona Shoe Woodleaf, NC *****

980-***-****

ac18a4@r.postjobfree.com

Highly motivated, results driven compliance specialist currently open to new employment opportunities. With many years of direct experience in quality assurance, direct testing, training and supervising success of fellow employees, I understand the importance of ensuring efficient operations, with the highest level of attention to detail, and working to ensure a team approach to success.

Ei, LLC. A Pharmaceutical Solutionworks, QA Compliance Specialist

June 2017 to August 2017 Kannapolis, NC

Performed Annual Product Reviews for drug and OTC products Investigate and maintain records for the product complaint system Participate in and/ or support audits performed by regulatory agencies and customers Support new product development initiatives

Ei, LLC. A Pharmaceutical Solutionworks, Microbiologist

January 2015 to Present Kannapolis, NC

Aseptic techniques involved in the use of biological safety hoods to reduce possibility for sample contamination. Safe handling of biological specimens such as bacterial, yeast, and mold species.

Growth promotion for incoming media for use in the lab. Microbial Limits Testing in accordance with specifications set forth by USP <61> and appropriate STP or SOP. Conduct environmental monitoring of microbiology laboratory to ensure compliance to company standards of cleanliness. Validation and performance of antimicrobial effectiveness testing of Category I-IV drug products to meet USP <51> standards.

Rowan Cabarrus Community College, Library Services Assistant

Salisbury, NC May 2016 to June 2017

This is a part time position that I work in conjunction as a Microbiologist.

Provided courteous and knowledgeable service to lab users. Ensured lab equipment is working properly, troubleshoot, report problems to supervisor. Maintained a strong familiarity with the various programs and technology being used in the lab. Adhered to lab and college procedures. Manage calendar of scheduled classes as needed for the computer instruction lab. Set up and maintenance of lab instruction classroom with regard to all computers and laptops in use for classroom instruction as well as A/V equipment and projector.

Carolina Spine and Pain, Lab Technician

June 2015 to April 2016 Mooresville, NC

This is a part time position, in which I provide urine drug screen analysis via APCI method, for identification of drug metabolites. This position requires superb attention to detail and adherence to chain of custody protocols.

Niagra Bottling, LLC, Quality Assurance Associate

November 2012 to January 2015 Mooresville, NC

Utilizing laboratory testing equipment to test raw materials and finished product goods for chemical and microbiological aspects to ensure product meets quality specifications. Calibrating lab equipment per calibration matrix and creating lab SOP’s and training aids for new lab personnel. Reporting any OOS data to QA Management and work with appropriate department to resolve issue while supervising/overseeing training of new QA lab personnel on laboratory practices and responsibilities. Recognizing quality issues on production floor, troubleshooting or notifying maintenance and production supervisor of issue. Audit production quality logs for accuracy, consistency, and to ensure product meets quality parameters set forth by QA. Complete non-conforming raw material and corrective action/preventive action claims in a timely manner

Monitoring and reporting wastewater pH utilizing AquaVX monitoring system and maintaining wastewater flow record, familiar with GMP’s of a FDA regulated manufacturing facility. Verification and calibration of WQMS probes on each production line. Overseeing the resolution of non-conforming areas. Audit company policies, procedures, and systems that affect product quality to assure compliance with the company’s quality system and good manufacturing processes. Prepare documents and reports. Work with production personnel in an advisory role to assist them with quality issues within their department while providing quality training to production employees.

Rowan Cabarrus Community College, Laboratory Instructor, Science/Math Tutor

Salisbury, NC August 2011 to November 2012

As a lab instructor, I had the privilege and honor to share my knowledge to help educate students. Specific responsibilities included classroom and laboratory procedure instruction of general science labs. Utilized technology and laboratory equipment to teach principles of general biology and human anatomy and physiology. Established and maintained a safe laboratory atmosphere with strict lab safety guidelines outlined before lab contact.

Rowan Regional Medical Center, Medical Unit Secretary

Salisbury, NC May 2012 to November 2012

Clerical responsibilities including: answered multi line phones, patient call bells, copying, faxing.

Maintained patient confidentiality adhering to HIPAA policy and protocol. Entry of physicians’ orders of various procedures and testing into emergency department data system accurately efficiently. Communicating interdepartmentally to convey information regarding patient status.

Education

Bachelor of Science in Medical Technology, May 2009

Catawba College, Salisbury, NC

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