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Manager Quality Assurance

Location:
Jenison, MI, 49428
Posted:
July 03, 2016

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Resume:

Ashraf Raad

**** **** **. **. ********, MI. *****. Phone: 616-***-****. acvjvr@r.postjobfree.com

SUMMARY

SQF, HACCP and Six-Sigma Black belt certified. Drives continuous improvement and compliance through LEAN concepts, visual management and standard work. Experience with sophisticated computer-controlled instruments with skills developed in Fortune 500 and Mid-size companies. Skills such as but not limited to; GCMS, HACCP, HPLC, Kaizen, JIT, SMED, TPS, Toyota Kata, 5S in a lean culture-food industrial and a FDA regulated Manufacture.

EDUCATION AND CERTIFICATIONS

Bachelor in Chemistry; Emphasis on Health Professions/Bio, University of South Florida, GPA 3.7

Associate In Science; Liberal Arts and Mathematics/Science, Rockland C. College, GPA 3.6

SQF level 3 practitioner certified, GFSI accredited ACCP MANAGER NEHA certified, IHA accredited

Six-Sigma Black Belt professional, MSI cert. # 395259 PCQI (FSMA Act) in progress certification by AFDO

PROFESSIONAL EXPERIENCE

Supply Chain / QA Manager Saudi Premium Food Co, Specialty Dried Fruit Division 1/2005-3/2016

Hired as a Quality Assurance and advanced to Supply Chain/QA Manager. During the ten years, I combined as needed responsibility and positions in production, purchasing, logistic, sanitation and continuous improvement.

Managed the US division of the company’s supply chain of a locally manufactured 15+ kinds of dried fruits.

Determined the best carrier and suppliers for our raw material base on its quality, constancy and bargain prices.

Facilitated the conversion to lean management, implemented TPS, Kaizen, SMED, JIT, 5S, Toyota Kata resulted a waste decrease in material/staff hours, a rise in quality/profit and environment safety with zero recall record.

Created, executed and audited company’s HACCP plans in comply with FSMA ACT/FDA regulation and new rules

Audited staff defiance to HSE, SOP, GMP, own hygiene, and the company to SQF, IOS/FDA regulation guidelines.

Tested the company’s raw materials supplies, finished products and rejected any confirmed decay materials.

Performed accident investigations; trained staff on PPE, chemical safety, first responder and sanitation plans.

Supervised the sanitation activities, performed the allergen swabbing and micro-bacterial analyses and etc..

Validated our vendors SQF / HACCP plans to ensure high standards set by us and ultimately by our customers.

Provided decisions for quality control issues as they arise, direct troubleshooting exercises when reference fail.

Trained and engaged every staff on SOP, SQF procedures, HACCP's CCP, the use of machineries and its Software.

Quality Assurance Scientist, Temp agency, Grand Rapids, MI. 03/2004-11/2004

Firmly and constantly monitored staff’s adherence to procedures in complies with SOP, GMP & FDA regulations.

Aided in developing SMED process resulted in a faster turn around, an increase of production, profit and saving.

Accountable for the lab’s performance and technical development; train staff with the Reference Laboratory.

Responsible for updating the laboratory requirements with the current GLP, GMP, SOP and future FDA policies.

Trained staff on the use of lab instruments with its software and on evaluating data with statistical programs.

Effectively validated, maintained and operated the laboratory instruments independently and sufficiently.

Scripted laboratory SOP for new product production to satisfy our client’s conditions and FDA requirements.

Tested the Labware empower software to assure accurate testing result and instrument authentication.

My reliable performance in HPLC, GC-MS, micro-bacterial testing rejected decay raw materials from being used in company’s production resulted in a large capital saving on supplies and labor expense.

Operated sophisticated computer-controlled instrumentation such as: HPLC (Water) Empower, GC-MS.

Perfected micro-bacterial analysis, analytical chemistry, immunoassay, ELISA, PCR and the use of Karl Ficher titration, surface tension meter, PH meter, MiniLab 53, SpectroLNF Q200 and DV2T viscometers and lots more.

Quality Assurance Chemist, National Testing Laboratory ARC, Detroit MI. 12/2001–03/2004

Valuable member of an investigational New Drug Product in a strict FDA regulated laboratory - Pharmaceutical and Blood Manufacturing with 96% successful runs on the production line compared to my colleagues of 72%.

Trained associates on a new FDA procedures to detect HIV and WN Virus at DNA/ RNA level plus the operating of the production line equipment such as Tecan GENESIS, Procleix Target Capture, Procleix HC+, HPLC, and etc..

Finest in laboratory performance and in following GMP techniques, such as in;

Hybridization Protection Assay (HPA) to capture targeted DNA sequence via oligonucleotide probes, acridinium ester (AE) and using the fluorescence release caused by torch separation for detection.

Real-Time Transcription Mediated Amplification (TMA), isothermal method that amplifies and captures targeted DNA or RNA sequence using polymerase chain reaction (PCR).

Aseptic techniques and sterile setting in all duties including the preparation of RNA Tag.

Participated in problem solving using lean system, root cause analysis tools such as CAPA, 6sigma, 5whys.

Recognized of being firm on procedures and practices in comply with lean system, SOPs, GMP and HSE.

Protected my company’s interest from any possible obstruction to the production line before it occurs. Such as, when I created a safeguard strategy to monitor the inventory turnaround time before raw material outage.

Biomedical Quality Control, (Notional Testing Laboratory ARC, Lansing MI.)

All analysis performed with the adherence to strict SOPs and incompliant with GMP, QMS and FDA guidelines.

Consulted and communicated with laboratory personnel, hospital staff and clients to clarify & resolve problems.

Performed various tests following SOP on donor’s specimens and interpreted data results with reference guide.

Validated instrument’s hardware and software. Maintained laboratory equipment. Assisted our new staff in training, troubleshooting, following SOPs, implementing the corrective and preventative of action and etc..

Medical Laboratory Assistant, Ford Bio Medical, Dearborn, MI 10/2001–11/2002

Preformed tests such as; Hematology Coagulation; Wet Chemistry; Blood banking; Immunology, etc.

Assist management in the operation of the laboratory, patient registration and interpret data results.

ACADEMIC EXPERIENCE

Scan Electron Microscopy at USF: Operated SEM, Prepared specimens via fixation, embedding, staining etc.

Research Associate, at UF College of Pharmacy: on quantitative and qualitative of Dynorphine peptides (HPLC).

Completed graduate courses: Pharmacology, Pharmacotherapy, Medicinal and Physical Chemistry, Microbiology, Anatomy and Physiology, Nucleotides, Statistics, Federal Laws, etc.

PROFESSIONAL AND ACDAMIC SKILLS

Such as but not limited to: HPLC, GC-MS, SEM, TEM, PCR, HPA, TGA, 5S, HACCP, Kaizen, 5Whys, 6sigma, SMED, Karl Fisher Titration, Bacterial cultures, Aseptic techniques, wet chemistry, QC, GMP, cGMP, GLP etc..

TRADES AND SKILLS TRAINED BY FORTUNE 500 COMPANIES

Skilled in database, spreadsheet and manufacturing software. Quick Books, MS suite, Word, Excel, Power Point, Publisher, Mac, all adobes, some SAS programs and ISO 9001:2015. Grade A mechanic with experience.

Teaching Certificate “DAPCEP” with 3 yrs of experience, Pharmacy intern certificate with 3 yrs of experience.

Chiron Pharmaceutical trained skills: Panther System, Procleix Tigris, DNA-RNA assays, TMA, HPA, PCR, etc..

Instrument installer, Grade A Mechanic/electrician and Auto part Machinist.

LANGUAGES AND HONORS

Strong written and oral communication skills in English, Arabic and Maltese.

Bachelor in Chemistry degree obtained in one year with 3.7 GPA from USF and a Phi Sigma Honor Society.

3804 32nd St. Se. Kentwood, MI. 49512. Phone: 616-***-****. acvjvr@r.postjobfree.com



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