1. Jamal Almustapha
14160 Red Hill Ave. Apt. #71 (714) 270-1631
Tustin, CA 92780 jamalalmustapha@gmail.com
Objective
A motivated and result-oriented professional seeking a manager position (or leadership equivalent) that offers professional
growth and development.
Education
Bachelor ofScience, Biology University ofCalifornia, Riverside
Classes of Interest:Microbiology, Cell Biology, Anatomy, Physiology, Immunology, Biochemistry, Endocrinology,
Invertebrate Zoology, Virology, Public Speaking
Professional Experience
CAPS Lead Microbiologist Central Admixture Pharmacy Services 06/2009 - Present
 Wrote/executed/reported validation/qualification projects and implemented microbiology quality testing in
compounding pharmacies in compliance with 503B under the Compounding Quality Act of 2013.
o Wrote/executed/reported the Installation/Operational/Performance Qualifications (IOPQ) of the BacT
Alert 3D Rapid Sterility System and created procedures for the implementation of rapid sterility testing in
compounding pharmacies.
o Wrote/executed/reported the IOPQ for the Charles River Endotoxin testing system and created the
procedure for the implementation of Endotoxin Testing in compounding pharmacies
o Wrote/executed/reported Product Method Validations for sterility and endotoxin testing for Anticipatory
Compounding products such as: Drug Delivery, Controlled Substances, and Anesthesia
 Experience in leading projects that involved traveling to CAPS pharmacies throughout the U.S. and coordinating with
various personnel from CAPS Quality and Operations in order to execute tasks.
 Experience in writing/executing/reporting Cleaning Validation studies for the qualification of existing sanitization
solutions or the implementation of new sanitization solutions (PeridoxRTU, Ygiene, IPA,Bleach, etc.)
 Experience in D-Value evaluations of Sanitization/Cleaning solutions on various laboratory and cleanroom surfaces.
 Experience in product validation, coordination, execution and reporting stability studies in order to increase the
Beyond Use Date (BUD) of CAPS Anticipatory products.
 Wrote/executed/reported Equipment Validations which includes the Installation/Operational/Performance
Qualifications of (IOPQ) Incubators,ovens and refrigerators (walk-In and stand-alone)
 Wrote/executed/reported the IOPQ for clean rooms in compounding pharmacies.
 Prepared/Coordinated/Reported Container Closure Integrity (CCI) studies for various containers such as: glass vials,
IV bags, syringes, pumps, etc.
 Experience in execution and reporting of Antibiotic Microbial Media Assays for Vancomycin to test the potency of
the antibiotic product using a challenge microorganism.
 Experience in the creation and revision of Standard Operating Procedures (SOPs),Test Procedures (TPs) and data
sheets for Microbiology testing and Quality Systems.
 Experience in the writing/executing/reporting of shipping studies to verify that the CAPS shipping container
configurations maintain simulated air and ground shipping, case drop simulation and internal container storage
temperature requirements.
 Performed technical review of test results for completeness and compliance to cGMPs and cGDPs to ensure that
excellent documentation, controls and traceability are in place to maintain data integrity.
 Lead training for lab technicians in all required Microbiology techniques and practices according to procedures and
regulation standards. Skills include Endotoxin Testing, Sterility Testing (Membrane Filtration and BacT Rapid
Sterility Testing), Particulate Matter Testing, Microbial Identification using Vitek 2, Growth Promotion and
Bioburden.
 Ensured all laboratory equipment is validated, maintained and calibrated according to cGMP’s and B Braun
requirements.
 Experience in the creation of monthly reports outlining accomplishments and goals for CAPS QC Microbiology.
 Experience in initiating and closing investigations of out-of- specification (OOS) test results and procedure /protocol
deviations
 Experience in coordinating the inventory of lab supplies for routine testing and special studies.

2. QC Associate II Central Admixture Pharmacy Services 01/ 2008 – 06/2009
 Executed and reported projects/routine testing for CAPS Anticipatory Compounding Products involving High-Risk
and Low/Medium Risk Admixture Compounding.
 Performed routine analysis of finished product, raw material or environmental samples according to established
specifications and procedures using various laboratory apparatus under minimal supervision of senior staff.
 Proficient in Sterility (Membrane Filtration), Particulate Matter Testing, Microbial Identification using Vitek 2,
Growth Promotion and Bioburden
 Recorded data in controlled notebooks, controlled data sheets,validated spreadsheets and/or LIMS including all
computational tasks and completes analysis report forms. Maintained neat and legible records and promptly and
accurately input data into LIMS.
 Performed routine laboratory maintenance and instrument upkeep as required. Prepared standards or test reagents
according to established procedures and specifications.
 Followed cGMPs,GLPs, SOPs,USP and FDA guidelines in all appropriate functions and notifies supervisor and/or
lead of any observed discrepancies in laboratory or plant operations.
 Prepared media, reagents,test samples and equipment as required.
 Experience in communicating with Quality and Operations personnel throughout CAPS pharmacies around the
country for validations, special projects and routine testing
 Reviewed, trended, and reported environmental monitoring data for CAPS pharmacies
 Proficient in finished product and raw material testing.
 Proficient in Environmental Monitoring techniques.
 Proficient in aseptic technique.
 Investigated non-conformance of routine testing specifications.
Product Development Lab Technician B Braun Medical 11/2006 – 01/2008
 Supported the EXCEED project in the Research and Development (R&D) Department. Duties consisted of
performing sterilization and functional testing for the development of blow-molded IV bags.
 Executed functional testing for the new Exceed Containers consisting of flow-rate, drop impact, collapsibility,
labeling, Med/Set port integrity and Sterilization of these samples by operating a sterilization simulator of the steam
sterilization units used at B.Braun Medical.
Technical Experience
Experience in leading and supporting the implementation quality testing in compounding pharmacies in compliance with
FDA regulations through the Installation/Operational/Performance Qualification (IOPQ) of testing equipment, creation of
testing procedures and the training of personnel.
Experience in leading Cleaning/Sanitization studies to qualify existing sanitization solutions or to implement new
sanitization solutions in CAPS pharmacies nationwide.
Experience in leading and supporting validations/qualifications of equipment using temperature monitoring systems.
Proficient in using the Kaye Validatior 2000 and various wireless loggers (Vaisala Veriteq VL-2000, Sensitech
TempTales, and 3M Temperature Loggers). Attended temperature and humidity validation seminars from Vaisala.
Experience in leading and supporting projects in relation to risk mitigation and cost savings through beyond use dating
(BUD) of Anticipatory Compounding (AC) products, product validations for quality testing (sterility, endotoxin testing)
and leading the implementation of new technologies (BacT/Alert rapid sterility testing).
Experience in the creation of standard operating procedures (SOPs),Test Procedures (TPs) and data sheets for all
Microbiological Testing executed by the CAPS Quality Microbiology Group. Experience in the implementation of
protocols by creating training modules and being a certified trainer.
Proficient in the following Microbiological tests: Sterility testing using the BacT Alert 3D System Rapid Sterility System
and (USP <71> Membrane Filtration method, Microbial identification using VITEK II, Raw Material/Solution
Bioburden, growth promotion/media sterility on various media in accordance to vendor specifications and USP,
Particulate matter testing using HIAC particulate matter counter machine using the light obstruction method and
Endotoxin LAL testing using the Kinetic Turbidimetric method.

3. Computer Skills
Proficient in the following computer programs:
 Microsoft (MS) Word
 MS Power Point
 MS Excel
 Sapphire LIMS system
 Observa data management system for the BacT/Alert rapid sterility
 Endosafe endotoxin data management program
 Pharmspec particulate matter data management system
 Kaye Validator 2000 data management system
 3M Temperature Loggers data management system
 Veriteq VL-2000 data management system
 Sensitech TempTale data management system.
Additional Information
Experience in supporting the Quality department during FDA audits through document/data acquisition, answering
technical questions in relation to quality testing and demonstrations of quality testing methods.
Experience in the acquisition of new technologies for Quality testing through Return On Investment (ROI)
calculations. Lead and supported the implementation of new technologies for quality testing in compounding
pharmacies.
Lead the Quality Microbiology team in routine testing and special projects by creating an environment of goal
oriented execution. Experience in training the CAPS Quality Microbiology team as well as quality personnel
employed in compounding pharmacies in different pharmacy locations throughout the country.
References
Thuy Chung , Central Admixture Pharmacy Services (CAPS) Sr. Supervisor: (714) 867-8240
Scott Snell, CAPS Quality Regional Manager: (562) 852-2604
Edgar Mendaros, CAPS Quality Director: (949) 302-0425