Quality Assurance Control

Jennifer Kolucki

** ****** ******, ***. #***, Quincy, MA 02170

908-***-**** ? **********@*******.***

Areas of Expertise

Analytical Development ? Method Validation & Transfer ? Good

Manufacturing Practices

ICH Guidelines ? Standard Operating Procedures ? US Pharmacopoeia ?

ICH Photostability

ICH Stability ? Radioactive Sample Analysis ? Controlled Substances ?

Reference Standard Characterization

Objective:

Performance driven analytical chemist with 8 years of cGxP experience

seeking new opportunities.

Professional Experience

Analytical Chemist II, CMC

Jan. 2009 - Present

Chemic Laboratories, Inc. - Canton, Massachusetts

* Initiates analytical development of stability indicating methods on all

new client research projects.

* Revises and writes SOPs and protocols for routine testing and method

transfers and validations.

* Performs method validations following USP, ICH and FDA guidelines.

* Executes routine assays following SOP's and Pharmacopoeial methods using

chromatographic and spectroscopic techniques.

* Experienced with in-process testing and short timelines.

* Responsible for all radioactive sample analysis for the CRO, including

the use of dialysis plates and FSA analysis.

* Develops methods for and analyzes various controlled substances.

* Set-up and performs routine maintenance on HPLC, GC and spectroscopic

instruments.

* Designs Microsoft Excel spreadsheets for complex data analysis to

minimize errors, Quality Assurance audit time and sample turnaround time.

* Coordinates and reviews data from outsourcing facilities ensuring data is

in full compliance.

* Responsible for testing and trending of stability data.

* Active in training program of new employees by explaining company

specific policies and cGMP lab practices and documentation.

* Reviews cGMP reports for method transfers and validation and writes

development and R&D reports.

* Troubleshoots various methods and instrumentation involved in out of

specification and out of trend investigations.

Analytical Chemist I, Quality Control

Feb. 2006 - Jan. 2009

Chemic Laboratories, Inc. - Canton, Massachusetts

* Executed routine assays following SOP's and Pharmacopoeial methods using

chromatographic and spectroscopic techniques.

* Responsible for all testing and trending of stability data.

* Designed Microsoft Excel spreadsheets for complex data analysis to

minimize errors, Quality Assurance audit time and sample turnaround time.

* Responsible for performing the annual OQ/PQ for the polarimeter, TOC

analyzer, and FTIR.

* Set-up and performed routine maintenance on GC and HPLC instruments.

Education and Credentials

Bachelor of Science in Chemistry, 2005

Boston College- Chestnut Hill, Massachusetts

Research: Designed a laboratory method for simulating atmospheric

transformations of soot aerosol particles.

Instrumentation and Skills

HPLC-DAD/RI/MS/FSA/Conductivity Detector, GC-FID, Karl Fischer, AA, FTIR,

UV/Vis, Polarimeter, TOC

Microsoft Excel, Word, PowerPoint, Agilent ChemStation, Perkin Elmer ProFSA

First Aid and CPR Certified, Blood Borne Pathogens Training

Interests and Hobbies

Cooking, traveling, ushering for theater and concert venues.

References provided upon request.

Contact this candidate