Quality Assurance Control

**** ***** *** *****, ***********, TN ***** Mobile: 423-***-****

Email: ***********@*****.***

EMPLOYMENT OBJECTIVE

Seeking employment in a leadership role as Supervisor, Team Leader or

Technical Support in a manufacturing or service environment with

operational responsibilities. My education and knowledge of manufacturing

and human resources will support continuous improvement and financial

growth to meet the company's business philosophy and financial objectives.

SUMMARY OF QUALIFICATIONS

. A responsible, loyal, ethical and trustworthy person.

. Managerial leadership experience in supervision and administrative

duties.

. Chemical manufacturing

. Ability to establish clear expectations, provides guidance, instills

accountability and communicates effectively at all levels of the

organization.

. Experienced in maximizing plant performance and quality assurance by

using lean manufacturing principles and safe work environment methods.

. Experience with the manufacturing of pharmaceutical and industrial grade

chemicals.

. Education and experience with AutoCAD, Engineering Design and Mathematic

calculations.

. In-depth knowledge working with Microbiology, General Chemistry, Cellular

Molecular Biology, Genetics and Biochemistry. Proficient with data

collection and statistics analysis.

. Knowledgeable in FDA, cGMP guidelines and best manufacturing practices.

. Experienced working with TDEC, FDA, DEA, ATF, and EPA regulations during

manufacturing, storage, and disposal of raw materials, manufactured

products, and waste streams/byproducts.

. ISO 9001:2008 Internal Auditor certified

. International Maritime Dangerous Goods (IMDG) certification

. Department of Transportation Hazardous Materials certification

. International Air Transport Association (IATA)/International Civil

Aviation Organization (ICAO) certification

. Root Cause Analysis Corrective Action Training

. New program/process implementation and project management including plant

layout, process flow. Experience in technical problem-solving and reading

equipment schematics.

. Good listing skills, balances points of view, and integrates ideas into

action.

. Ability to analyze problems, both technical and behavioral in nature, and

provide practical solutions.

. Demonstrated track record for assuming increasing responsibilities.

. Takes initiative and is able to efficiently handle a variety of tasks and

responsibilities simultaneously; works well under pressure. Meets

deadlines; is adept at finding ways to speed up a task.

. Successfully transitioned Colonial Chemical, Inc. into ISO 9002:2008

certification.

. Chemical-terrorism Vulnerability Information (CVI) Authorized User

EMPLOYMENT HISTORY

COLONIAL CHEMICAL, INC. South Pittsburg, TN 2010 -

Present

Position: Environmental, Health, Safety, and Regulatory Manager

. Ensure compliance with hazardous waste regulations

. Ensure compliance with environmental regulations

. Ensure compliance with waste water regulations

. Developed and administered new-hire training

. Submit EPA Pre-manufacturing Notices (PMN)

. Submit Canadian Domestic Substance List (DSL) registration dossier

. Submit European Union Registration, Evaluation, Authorization, and

Restriction of Chemical Substances legislation (REACH) dossier

. Maintain current registration with Department of Homeland Security, Drug

Enforcement Administration, and Environmental Protection Agency

. Complete customer regulatory questionnaires

. Conduct monthly OSHA-required safety training

. Ensure safe operation of physical plant

(page 2, continued)

. Conduct jobsite safety audits

. Maintain and author material safety data sheets (MSDS) for raw materials

and finished products

. Author ISO procedures

. Create and issue North American Free Trade Agreement (NAFTA) certificates

to non-domestic customers

. Conduct quarterly Internal ISO audits

Position: Manager Quality Assurance

. Ensure compliance with ISO procedures

. Conduct daily audits of quality control, production, and shipping

departments

. Production batch record review for compliance

. Quality control analysis review for compliance

. Ensure quality of incoming raw materials

CHATTEM CHEMICALS, INC. (Now SUNPHARMA) Chattanooga, TN 2005 -

2008

Production Supervisor - Production responsibility for manufacturing glycin,

aluminum chloride and Pamabrom. Serving industries such as; Johnson and

Johnson, Nestle, Baxter Bioscience, Bayer, GlaxoSmitKlein.

. Assured compliance with TDEC, FDA, DEA, ATF, and EPA regulations during

manufacturing, storage, and disposal of raw materials, manufactured

products, and waste streams/byproducts.

. Member of the Safety Committee. Performed weekly hazardous waste

collection site audits.

. Ensured that customer requirements were met in cooperation with the sales

team.

. Authored, revised, and reviewed SOPs.

. Assisted in the development of corrective action plans (CAPA).

. Identified the root cause of customer complaints, made recommendations

and implemented corrective action.

. Conducted Quality Engineering reviews of design and documentation to

ensure compliance with all company requirements. Tracked and analyzed

manufacturing data.

. Notified management team of significant issues or developments identified

during the quality assurance process and outlined procedures to correct

any problems.

. Prepared and presented technical information to the management team.

. Instrumental in developing protocol to reduce false positive bacterial

contamination in water system.

. Assisted in the production scale-up of a key pharmaceuticals.

. Supervised15 employees during the absence of the operations manager.

. Completed batch records in compliance with FDA and cGMP guidelines.

. Managed production schedule to meet crucial deadlines for product orders.

. Developed and implemented a successful chemical operator training

program.

. Maintained a continuous improvement plan

Quality Control Analyst

. Utilized advanced laboratory instruments to analyze raw materials and

finished products.

. Completed laboratory analysis according to cGMP standards. Strictly

followed USP and EU tests

and guidelines for establishing quality of finished and intermediate

products.

. Conducted analysis of raw materials for use in pharmaceutical and

industrial goods.

. Inventoried and ordered lab supplies and chemicals.

MEMORIAL HOSPITAL Chattanooga, TN. 2002 -

2005

Emergency Room Technician

. Assisted in medical/surgical procedures and general patient care.

. Administered EKGs on emergency room patients and CPR certified.

. Used phlebotomy skills to obtain blood from children, adolescent, middle

age, and geriatric patients.

(page 3, continued)

FREED HARDEMAN UNIVERSITY Henderson, TN 2000 -

2002

Dorm Resident Assistant

. Worked closely with the Dean of Students in ensuring all students

conformed to the policies and procedures set forth by the university to

include supervision of dorm residents.

Cancer Lab Research Assistant

. Supplied research data to laboratory director.

. Cultured live cancer cell lines for future research.

. Proofread institutional findings for laboratory director to present

before institutional review board.

UNIVERSITY SURGICAL ASSOCIATES Chattanooga, TN May 2000

- August 2000

Research Intern

. Assisted medical students in the skills lab.

. Reviewed patient records for inclusion into or exclusion from

pharmaceutical trial.

VOLUNTEER EXPERIENCE

ERLANGER HOSPITAL Chattanooga, TN May

2000 - July 2000

Surgical Second Assistant

. Scrubbed in on various surgical cases.

. Assisted the attending physician by holding retractors and cutting

sutures.

EDUCATION

. Boyd-Buchanan Chattanooga, TN Graduated

1998

. Bachelor of Science Freed-Hardeman University, Henderson, TN

Graduated 2002

. Chattanooga State Community College Chattanooga, TN (Non degreed)

2003 and 2004

. International Maritime Dangerous Goods (IMDG) certification

2010

. Department of Transportation Hazardous Materials certification

2010

. International Air Transport Association (IATA)/International Civil

Aviation Organization (ICAO) certification 2010

. ISO 9001:2008 Internal Auditor certification

2010

. Root Cause Analysis Corrective Action training

2010

. Chemical-terrorism Vulnerability Information (CVI) training

2010

COMPUTER SKILLS

. Proficient in Microsoft tools including Platinum for Windows.

. Proficient in AutoCAD and Three-dimensional computer modeling.

. Utilized Actrix, Visio, Crystal Reports, and Calibration Management.

. Knowledge of Chempax VB software

HONORS AND ACTIVITIES

. Society of Automotive Engineers.

. Pre-medical scholarship and High ACT score scholarship.

. Student Government Association Assistant Vice President.

. Academic Affairs Committee and Rules and Regulations Committee.

Reference upon request

Contact this candidate