Quality Assurance Manager

Fritz G. Neptune

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

Garnerville NY *0923

abn6mb@r.postjobfree.com

(845) 642 - 1172

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Objective: QA Supervisor/ QA Manager

I have learned through my experience that with proper motivation and a

strong work ethic one can accomplish great success. I have become quite

efficient and knowledgeable with understanding the necessities of being

productive and maintaining safety with regards to quality assurance. With

each facility that I worked for, I helped train, develop methods and helped

productivity while influencing GMP guidelines. I wish to use the knowledge

that I have learned to preside as the manager of the quality control

laboratory.

Core competencies:

. Excellent leadership/troubleshooting skills and working knowledge of

GCP, GLP, or cGMP

. Lead compliance audits and maintained accurate instrument records

. Coordinated with internal and external laboratories

. Laboratory improvement/Root cause Analysis

. Writing Lab validations, SOP's, WI, tech reports, and deviations

. COA and laboratory test approvals.

Summary of Qualifications

2009- January 2013 Adecco/Stryker Orthopaedics Mahwah,

NJ

Research and Development Chemist

Responsibilities:

. IQ/OQ and PM instrumentation validations

. Reviewed Historical Data to help medical device quality improvement.

. Investigating customer complaints, capa's, and validation protocols

. Releasing product in a timely matter

. Provided quality oversight of external laboratories, including

contract manufacturers, and testing labs that provided services to the

company.

. Reported to senior management on the status of compliance; advise

management of potential issues; ensured the implementation of

appropriate corrective actions

. Traveled Internationally to ensure laboratory set up and compliance

. Maintaining and developing methods for GC-FID, GC-MS, ICP and HPLC,

. Analyzing medical implants metals: titanium, chromium, aluminum as

well as plastics: polyethylene and polyurethane plastics for organic

residuals.

. Analyzing pesticides, leading research and development on antibiotics

as well other manufacturing agents.

. Have experience in all the latest tools and techniques in the chemical

laboratory

. Familiar with medical, cosmetics and food regulations in U.S.,

European, Asian regulation.

. LIM's Software Validation

2007- 2009 Naturex South Hackensack, NJ

Analytical Chemist

Responsibilities:

. Performed analysis on botanicals raw materials, batches and finished

products.

. Analysis of herbicide, insecticides and fungicides on nutraceuticals

. Ensured products were within specification requirements.

. I took the responsibility of enhancing method development and improved

laboratory testing

. Took the lead with drastically reducing 6 months of unidentified

inventory.

. Performed weekly calibrations on machinery, set up maintenance

contract with agilent technologies and helped fixed HPLC machine that

was down for a year.

. Training other employees on new methods

2004- 2007 Nice Pak Orangeburg, NY

Lead Chemist

Responsibilities:

. Supervised a team of 8 technicians on rotating shifts in quality

assurance department.

. Handled the tasks of preventative maintenance, implementing and

developing new methods while maintaining quality system policies

. TOC, UV-Vis Spectroscopy, HPLC, GC-FID, wet chemistry analysis

. Attended OOS and non-conformance meetings and performed audits of

other departments within the facility.

. Carried out control analyses of raw materials, finished products, and

stability analysis. Ensured compliance with USP, ASTM, European, FCC

methodologies

. Helped maintain laboratory compliance under 6 month lab renovations.

. Speaking with external laboratories and internal department about

product release, COA's, and product non-conformance

. Traveled to other laboratory to aid method development

Education: Rockland Community College A.A.S Math and Science 2000

State University at Purchase B.A. Chemistry

2004

Manhattanville College

M.S. Organizational Leadership and

Strategic Management 2011

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