Project Manager Quality Assurance
Resume:
Rowaida Gaffar
Germantown, MD 20876
*************@*******.***
Education
University of Wuzerburg, Germany
Executive Masters of Business Administration
Date of Graduation: October 2012
McGill University, Montreal, Quebec, Canada
M.Sc. Food Science
Date of Graduation: January 1999
University of Western Ontario, London, Ontario, Canada
Honors B.Sc. Plant Science,
Date of Graduation: June 1996
Professional Experience
Qiagen Inc., Gaithersburg, Maryland October 2006-Present
Manager, R&D Management/Compliance
1. Maintain quality management system program to ensure FDA, GMP, GDP, ISO, GLP and OSHA requirements are followed within R&D.
2. Manage the calibration and qualification program for all lab equipment and prototypes.
3. Prepare and review validation protocols.
4. Review deviations, investigations, action items and assist with closure.
5. Participate and coordinate preparation of ISO, FDA and other regulatory compliance audits.
6. Work with senior management to respond to CAPAs in a timely manner.
7. Manage internal audit program. Maintain metrics to track improvements and ensure corrective actions are implemented.
8. Create, revise, review and sign off on MMRs, SOPs, forms and specifications.
9. Manage the department's training program by ensuring staff are trained on the proper SOPs according to their job functions and according to the lab, safety and compliance processes.
10. Liaison for compliance, document systems, marketing, EHS, supplier quality, purchasing, facilities to ensure required processes are followed.
11. Establish and review contracts with various vendors to ensure R&D is compliant.
12. Plan and monitor budget requirements. Responsible for resource management, equipment, instrumentation, supplies and personnel.
13. Supervise, train and motivate direct reports and conduct yearly performance evaluations.
14. Project manager for the move and shut down of the 9WW and R&D pilot plant building in 2009 and 2012.
15. Project manager for the R&D site move to Germantown facility.
16. Involved in obtaining ISO 9001:2008 certification of Frederick R&D laboratories.
17. Involved in commercial transfer of R&D products to operations.
18. Frequent collaborations with global R&D counterparts on various projects.
19. Involved in multiple continuous improvement activities with a cross functional team from multiple Qiagen sites.
Baxter Bioscience, Beltsville, Maryland March 2005- October 2006
Quality Specialist III
1. Reviewed exceptions and investigations pertaining to product and processes; partnered with owners for closure by using problem solving tools.
2. Working knowledge of FDA, EPA, USDA, MHRA, DMA, Health Canada, ISO, ICH, and WHO guidelines and regulations, as well as Baxter Quality Systems.
3. Reviewed division procedure requirements and other new procedures in a timely manner; assisted document owners for closure through gap analysis.
4. Ensured timely review of test records associated with in-process, finished product and stability materials.
5. Investigated customer complaints and generated reports associated with the complaints.
1. Participated in regulatory inspections; maintained a working knowledge of regulatory requirements according to ISO 19001.
2. Maintained the change control system through site specific SOPs and partnered with document requestors for timely closure of changes.
3. Provided the quality/technical experience to other departments for quality activities related within the department as it relates to the strategic planning of the site.
4. Scheduled and oversaw the quarterly management review program.
5. Initiated process and monitored the progress of any exception, Change Control or Action Items.
6. Ensured timely review of test records associated with in-process, finished product and stability materials.
7. Managed Quality Systems, Quality Assurance Product Release and Quality Assurance Materials Control Groups on an as needed basis.
8. All other duties as assigned.
Baxter Bioscience, Beltsville, Maryland January 2001- March 2005
Senior Quality Analyst/Quality Control
1. Scheduled, oversaw and participated in the execution of daily duties of sample and testing flow as a shift lead.
2. Managed the raw materials program to assure sampling and testing of raw materials in compliance with GMP by using USP and EP procedures.
3. Performed chemical analysis of raw materials, intermediates, bulk, final product and stability samples.
4. Operated and performed required routine maintenance on laboratory equipments.
5. Wrote and revised SOPs, Raw Material Specification (RMS), Test Records (TRs) and Batch Records (BRs) for test methods, equipment use and maintenance.
6. Performed monthly audits of laboratory procedures and processes.
7. Performed monthly trend analysis to monitor process, performance as well as accomplishments and challenges of the group to manager.
8. Worked closely with Materials Management, Quality Control, Quality Assurance and Manufacturing to assure our commitments are met for our internal and external customers.
9. Participated on cross-functional teams and strategic planning processes and provided feedback to the department.
10. Identified and wrote exceptions and OOS Investigations related to testing activities and participated in the implementation of quality systems and corrective actions within the laboratory.
Daminco Inc., Ontario, Canada April 2000 – September 2000
Quality Control Lab Technician
1. Performed analysis on raw ingredients, incoming oils and finished products such as PV, IV, FFA, RCS, viscosity, specific gravity, pH, %salt, granulation and more.
2. Released and sampled raw ingredients for production use and resale. Collected and documented data of raw materials, and finished product.
3. Issued Certificate of Analysis and Specification/Product Information Sheets for various food industries and pharmaceutical companies.
McGill University, Quebec, Canada February 1999 – September 1999
Research Assistant
1. Successfully extracted fat from various Canadian dairy products using different extracting procedures.
2. Programmed and set up gas chromatography for analysis of fatty acids.
3. Studied the different fatty acids in various dairy products.
4. Performed instrument troubleshooting.
Honors/Awards
1. Recipient of Qiagen’s departmental award for outstanding R&D support by American Management Council (AMC) in 2008.
2. Awarded 2 year scholarship for the Qiagen’s Executive MBA program in 2010.
3. Identified as one of Qiagen’s key employees in 2011 and awarded company stocks.
4. Recipient of Baxter’s departmental award in 2004.
PUBLICATIONS:
Gaffar, R., Kermasha, S. and Bisakowsli, B. 1999. Biocatalysis of immobilized chlorophyllase in a ternary micellar system. Journal of Biotechnology 74: 45-55
Gaffar, R., Kermasha, S. and Bisakowski, B. 2000. Biocatalysis of silica gel-immobilized chlorophyllase in a ternary micellar system. Process Biochemistry 15: 32-42.
Reference Available Upon Request
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