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Software Quality Assurance

Location:
Lawrenceville, Georgia, 30046, United States
Posted:
December 30, 2018

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Resume:

Courtney D. Jenkins

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

Lawrenceville, Georgia 30046

678-***-****

OBJECTIVE

To use my strong analytical and organizational skills with my extensive research experience in the field of analytical chemistry in a challenging environment that permits growth and development.

EDUCATION

Tufts University (Medford, MA) B.S. in Chemistry, May 1992

Tufts University (Medford, MA) B.A. in American History, May 1992

WORK HISTORY

WORK HISTORY

PURAC AMERICA: BIOMATERIALS

(CORBION: INTERNATIONAL BIORESORBABLE POLYMER/MEDICAL DEVICE COMPANY)

April 2016-Present

Tucker Georgia

Chemist

1.Developed and validated approved LC, LCMS, UPLC, and GC/GCMS for generic tablets and OTC products

including suspensions and creams.

2.Researched pharmaceutical active ingredients and wrote pre-formulation reports in regards to

degradation products, pharmokinetics, and chemical pathways for OTC creams and lotions and

generic suspensions and emulsions.

3.Wrote validation reports, created stability and finished product procedures, and outlined specification sheets for the R&D and QC departments

4. Perform and lead FDA Audits as well as maintain training for cGMP, and CGLP in facility

5. Write and review SOPs in ISO 9001 Certified facility

6. Write Process Validations Protocols and Reports for bioresobable polymers

NAMASTE LABORATORIES

September 2014-Apirl 2016

Analytical Chemist

1.Design protocols and manufacture production batches ranging in sizes from 200 pounds to 15,000 pounds.

2.Perform HPLC/MS and GC/MS analysis on raw materials for production release using Waters 2695 and Empower software, as well as GC 6890 using Chemstation software.

3.Formulated over 35 formulas for ethnic hair care line for professional and retail line that are sold on the market.

4.Develop Analytical methods and validate using HPLC waters’ 2695 and Agilent 6890.

5.Run samples using ICP-MS Perkin Elmer, perform wet chemistry titrations, and ran samples using FTIR and UV-Vis

January2010-Present

(DESIGN ESENTIALS)

(DEACATUR, GA)

Analytical Chemist

1.Design protocols and manufacture production batches ranging in sizes from 200 ponds to 15,000 pounds.

2.Perform HPLC/MS and GC/MS analysis on raw materials for production release using Waters 2695 and Empower software, as well as GC 6890 using Chemstation software.

3.Formulated over 35 formulas for ethnic hair care line for professional and retail line for Design Essentials that are sold on the market.

4.Develop hair line using new inventive ingredients with natural claims of mineral free, paraben free, petrolatum free, silicone free, phthalate free, and TEA Free, and DEA Free

5.Perform wet chemistry titrations and run samples with UV-VIS and AA

July 2006- December 2009

PFEIFFER PHARMACEUTICAL COMPANY/S.S.S. COMPANY

(ATLANTA, GA)

Formulations Chemist

1.Developed and validated approved LC/LCMS and GC/GCMS methods for finished pharmaceutical OTC skin care products creams, ointments, vitamin tablets, and vitamin liquid, using Empower software on 2695 and Chemstation software on 1100 HPLC and 6890 GC.

2.Formulated skin care products for oily and dry skin, skin care lotion products using lanolin based formulations, creams, ointments, emulsions, and shampoos for cosmetic product line of the company.

3.Formulated daily vitamin tablets and high potency vitamin tonic for nutritional product line of the company.

4.Reviewed and validated approved process validations for batching skin care products and creams, and batch records for vitamin tablets.

5.Run samples and validate methods on ANDA and NDA products.

6.Perform wet chemistry titrations and run samples with Perkin Elmer AA.

7.Wrote pre-formulation reports in regards to degradation products for lotions and vitamin tablets.

January 2002- June 2006

MIKART PHARMACEUTICAL COMPANY

(ATLANTA, GA)

Chemist

4.Developed and validated approved LC, LCMS, UPLC, and GC/GCMS for generic tablets and OTC products

including suspensions and creams, using Empower software 2695 HPLC and Agilent 6890 GC using Empower software.

5.Researched pharmaceutical active ingredients and wrote pre-formulation reports in regards to

degradation products, pharmokinetics, and chemical pathways for OTC creams and lotions and

generic suspensions and emulsions.

6.Wrote validation reports, created stability and finished product procedures, and outlined specification sheets for the R&D and QC departments.

April 1999 – January 2002

JOHNSON & JOHNSON – NORAMCO PHARMACEUTICAL COMPANY

(ATHENS, GA)

Quality Assurance Supervisor

1.Performed various wet chemistry techniques using USP methods(AA, FTIR, UV-Vis, etc)

on individual pharmaceutical raw material, intermediate and final products.

2.Ran Agilent’s 6890 GC with FID, NPD, ECD and 1100 HPLC on various pharmaceutical products that NORAMCO makes for stability purposes using Chemstation software.

3.Tested controlled substances (i.e.oxycodone hydrochloride, hydrocodone bitartrate, morphine sulfate, and etc.) in regards to LC/MS (Triple Quadipole) and MS/MS, and GC /MS Ion Trap Detection, in order to provide quality assurance and batch release.

August 1998 – April 1999

ENVIRONMENTAL CHEMICAL CORPORTION

(CINCINNATI, OH)

Analytical Chemist

1.Analyzed soil and water samples for the U.S. Army Corps of Engineers to detect explosives used

Waters’ 2690 HPLC

2.Analyzed PAH (Polyaromatic Hydrocarbon) by Waters’ 2690 HPLC.

3.Analyzed anions (Chloride, Bromide, Nitrates, and Phosphates) by Ion Chromatography.

September 1997 – August 1998

PROCTOR & GAMBLE’S SHARON WOODS TECHNICAL CENTER

(CINCINNATI, OH)

Analytical Chemist – Skin Care Development

1.Used HPLC procedures in the testing of such components as salicylic acid, resorcinol, methyl

and propyl parabens, and benzyl peroxide in Clearasil, Noxzema, Oil of Olay and other various P&G products.

2.Used Hewlett-Packard GC techniques with FID, ECD, and GC/MS Ion Trap Detection, VL and S

modules, which involved testing of raw materials in Noxzema, astringent and toners, and

other various P&G products.

January 1997 - August 1998

PROCTOR & GAMBLE’S WINTON HILL INTERNATION BUILDING

(CINCINNATI, OH)

Analytical Chemist/Formulations – Commercial Department

1.Researched polymers that went into formulations of P&G floor cleaners, high gloss finish and multi-purpose glass cleaner.

2.Performed and ran instrumentation on stability tests on various proteins and polymers that went into formulations by the use of GC with FID, and GC/MS.

3.Formulated on micro-scale P&G floor cleaners and develop new floor cleaner to be marketed nationally.

ACADEMIC HONORS & AWARDS

Member of Society of Cosmetic Chemists

Member of Dean’s List at Tufts University

Member of Society of Cosmetic Chemists

COMPUTER SKILLS

Microsoft Word, Excel and Access, Formulator Software, Millennium 32 and 2.14, Empower, Chemstation, PC in a network Environment such as Pathworks and Novell, Bruker’s Ion-Trap Software, Oracle.



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