Quality Control Manager

HALIMA R. IBRAHIM •*************@*****.***

**** *. ******* ****** *******, IL. 60619 •H 773-***-**** •C 773-***-****

OBJECTIVE:

A quick-witted individual looking for global developmental growth in Regulatory.

QUALIFICATIONS:

Clinical & Regulatory Compliance with, 21CFR & Forms 1571/1572/3674 GXP, ICH GCP Endotoxin, Biotek & Aria Flow Cytometer Analytical Method Development & Validation (IQ/OQ/PQ) Microsoft Office/Mac (Power Point, Excel & Word), Visio, Blackboard.

EXPERIENCE:

•University of Chicago-Biological Shared Division/Share Office Research-Chicago, IL.

Regulatory Affairs Manager-September 2009-Present

•Perform study start-up & closeout for T Reg Cells, Type I Diabetes-Stem Cell & Hematology/Oncology Melanoma study protocols involving human subjects.

•Develop & implement approaches for site recruitment, selection, initiation of patient enrollment strategies & site visits.

• Compile, review and develop labeling strategies for filing ANDA/NDAs FDA submissions.

• Perform site management to strategize, organize & complete informed consent, subject follow-up & adverse event reports with human subjects. Maintain, record & change control to ensure risk management & compliance with applicable regulations.

•Review current protocols/policies & procedures to obtain & maintain accreditation by continued compliance with the guidelines for CLIA/CAP.

•Chicago Department of Public Health-Food Protection Division-Chicago, IL.

Compliance Sanitarian II-August 2002-August 2009

•Ensure compliance of establishments that process, dispense & purvey food & dairy products with State, City & local government. Assist with sanitation & development of a HACCP procedure as a preventative aspect. Serving as a consultant to companies as follows by implementing new programs & improving existing programs.

•Developing Food Safety & Food Security techniques with Bioterrorism Team (BT).

•Inspect swimming pools/spas & ensure compliance with FDA/Regulatory & local laws.

•Enforcing potentially hazardous food recalls with FDA due to potential health risks & unstable shelf life. Implement corrective actions & developing a preventative action to avoid reoccurring circumstances.

•Revising the CDPH Municipal code to concur with the State of Illinois & FDA Food Code.

•Obtain & transport samples to IDPH lab per CDC request for chemistry & microbial testing.

•Apotex Corp.-Vernon Hills, IL. November 1999-July 2002

Chemist-November 2000-July 2002

•Developed, validated, & implemented methods for the analysis of API’s (potency, residual solvents, impurity particle size), Finished products (assay, degradation & cleaning validation).

•Executed analysis of R & D finished products from manufacturing through stability & document all test performed. Prepared protocols for method transfer from R & D to Quality Control Department & worked closely with Regulatory Affairs by organizing the CMC section

•Reviewed protocols of Clinical Studies & analytical data, analytical protocols, validation reports, test methods, SOPs, COAs, stability reports & product transfer protocols.

Quality Control Chemist-December 1999-November 2000

•Executed analysis for release of raw materials, finished product & preservatives following pharmacopeias monographs (USP).

•Worked closely with the R & D & manufacturing department for the qualification of new API’s & timely release raw materials for the production of manufacturing.

•Perform analytical operations with analytical methods using HP 1100 to create new methods.

•Audit notebooks, analytical protocols, validation reports & test methods with cGMP/cGLP.

•Prepare SOPs to perform qualification, monitoring & auditing of clinical studies.

•Trinity Hospital-Chicago, IL.

Regulatory Affairs Manager-Chicago, IL June 1994-August 1999

• Worked closely with Principal Investigator Dr. Olowopopo & Dr. Scott in Obstetrics/Gynecology with screening, enrollment, informed consent, subject follow-up & adverse event reports with human subject.

• Educated & served as a liaison to patients during routine assessments & monitoring for adverse events. Communicate effectively with patients & Principal Investigators at all times to ensure protocols met compliance per FDA.

•Performed in-house monitoring & assisted with case report form development. Responsible for documenting patient study information in centralized database system & tracking registration package for regulatory submission. Attended national & international required off site seminars/meetings.

EDUCATION:

•University of Chicago- Chicago, IL.

CITI-GCP & Track I: Fundamentals of CRA Certification- Nov 2010

Track II: Essentials of Patient Oriented Research Course (EPOR)-Winter 2011

•Northeastern Illinois University, Chicago, IL. GPA: 3.7/4.0

Masters of Science in Analytical Chemistry August 2006.

Thesis: Recycling Used Batteries with Emphasis on Household Used Batteries

•Southern Illinois University at Carbondale, Carbondale, IL.

Bachelors of Arts, August 1998. Major: Biological Sciences Minor: Chemistry

Independent Research:

Attended Symposiums on tropical diseases, & researched T3 & T4 hormones (1997)

Recycling Used Batteries with Emphasis on Household Used Batteries (2006)

Memberships:

International Society of Cellular Therapy (ISCT)

College of American Pathology

National Environmental Health Association (NEHA)

Continuing Education:

PACT Webinar

August 11, 2011 “Preparing for a FDA Inspection”

October 15, 2009 “cGMP for Phase 1 INDs: Manufacturing Cell Therapy Products”

CERTIFICATIONS: Shipping of Hazardous Materials, Shipping of Infectious Substances, HIPPA, Occupational Safety & Health Administration (OSHA), State of IL General Use Pesticides License, State of IL FSSMC Instructor, IL Department of Public Health Swimming Pool Operator Certification, State of Illinois/City of Chicago Food Sanitation Certificate, State of IL License in Environmental Health Practitioner in Training, Bioterrorism Preparedness, HACCP Training, Food Safety & Food Security Training, Smoking & Curing Training.

REFERENCES: Available upon request

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