Quality Assurance Manager

Professional Profile: A self motivated and clearly dedicated individuidual with a proven record handling complex project development, implementation, and management in large- scale organizations

Summary of Qualification:

9 years of hands-on experience in Laboratory and Quality Management developing, implementing, and managing programs. . Extensive knowledge of state and federal regulations such as: FDA, OSHA, CHILA, ISO, GLP and cGMP. A masters degree in Management with concentrations in Health Care and Human Resource Management also six sigma trained.Hands-on manager that also a persuasive communicator with well-developed presentation and negotiation skills. Able to develop productive relationships with colleagues, customers and staff at all levels

Professional Experience

Grifols Biomat USA _____________________________________________________Present

Manager

Manage and supervise the day to day activities within the facility. Also evaluate and coordinate the activities of the personnel within the quality department to ensure that the company’s short and long term objectives and goals are met. Provide strategic direction by planning, developing, and implementing tools to support continuous improvement that results in better customer service, lower cost, and high product quality.

• Responsible for all personnel functions including: hiring, developing and training of staff.

• Lead and provide support for corporate quality initiatives to ensure corrective and preventive actions are in place in an effort to maintain quality products.

• Perform internal audit to analyze procedures with regards to quality assurance in effort to recommend changes and process improvements as need.

• Travel other facilities within the company to refine quality systems by creating long term corrective actions and strategic plans

International BioResource/Octapharma Plasma_________________ 01/2009-10/2010

Senior Quality Supervisor

Provide technical assistance to staff, operations, and donor centers for continuous improvement within the company. Ensure compliance with all applicable state, federal, customers and IBR requirements. Train staff, as required, on new SOPs, SOP revisions, and corrective and preventive actions

• Assisted in the execution and the development of training for the company after the acquisition to Octapharma Plasma.

• Traveled to other center to provide mentoring and guidance to other Quality Supervisor’s

• Designated trainer- Train new Quality supervisor’s for the company

• Lead the company in several successful audit s with no findings including FDA, PPTA, COLA, and EU.

• Approve all validation and calibrations within the center

BioLife Plasma Services, Hoover, AL____________________________________05/2006-10/2008

Lead Supervising Specialist

Supervised laboratory operations for the Baxter’s Bioscience division, which is the leading producer of both plasma-based and recombinant clotting factors for hemophilia. Developed lean strategies and set the priorities, objectives, and direction of Continuous Improvement activities within the Laboratory. Assist in the creation and modifications of standard operating procedures as needed to improve and sustain improvements with the laboratory. .

• Worked in conjunction with Laboratory Quality Assurance Manager in the implementation, monitoring, and maintenance of the laboratory quality systems.

• Developed protocols for new instrumentation, and processes also perform the validation and test cases for the new instrumentation.

• Served as the key contact and consultant for regulatory inspections and system validation projects

BioLife, Hoover, AL

Laboratory Operations Quality Coordinator---------------------------------03/2005-05/2006

Developed and implemented a system of audits and compliance to attain effective ways to sustain the quality of testing processes within the laboratory. Also lead several kaizen projects in an effort to improve the work flow and quality within the laboratory.

• Performed internal studies and audits on clients and product development to evaluate if processes an deliverables fulfill the requirements and standard for quality

• Maintained control within the lab by ensuring compliance of State and Federal regulations, FDA,OSHA,CLIA and cGMP

• Lead the audit team in performing audits of subcontractors who provide support for regulated work with the laboratory

BioLife, Hoover, AL

Training Specialist____________________________________________06/2003-03/2005

Train new staff on instrumentation through BioLife’s Standard Operation Procedures. Conduct monthly training meeting and provide ongoing mentoring for new staff. Developed and coordinate training seminar and workshops on motivating and developing staff.

• Reduced staff turnover by 15%

• Designed cross training program for new and existing staff, and collaborated with human resources manager to design and co-lead offsite training

• Developed a system to support audit and assessments to ensure corrective action plans were in place for the laboratory

• Certified in HIV, HBsag, HCV, Syphilis, Serum Protein Electrophoresis, and confirmatory testing

• Reduced turn around time for confirmatory testing by 9 days

Education

Troy University, Montgomery, AL

Masters Degree (08/2007-10/2008)

Management: concentration Human Resource Management &

Health Care Management

G.P.A 3.5

Related courses: Corporate Finance, Human Resource,

Business Research Design, Strategic Management,

Administrative Law, Accounting, Public Administration, Organizational

Behavior, Public Personnel Management, Capital Budgeting, General

Business Management

Stillman College, Tuscaloosa, AL

Bachelor’s Degree

Biology major (chemistry minor)

G.P.A 3.2

Additional Skills

• Quality Management Certification-expected completion date 03/2012

• Quality Audit Certification- expected completion date 03/3012

• Certified in Lean Manufacturing Strategies

• Certified in 5s (waste prevention tactics) tactics, and Project analysis and design

• Trained and certified on writing, revising and developing new standard operation procedures.

• Strong interpersonal and communication skills

• Excellent multi-tasking skills

• Guide the development and growth of staff

• Highly organized, ambitious analytical thinker

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