yyyyyy x. yyyyyy

(xxx-xxx-xxxx • abc@xyz.com

 

 

quality-focused leader specializing in driving operations compliance, creating targeted sops, designing enhanced program processes and systems, analyzing a high-volume of data, and building top-performing teams eager to offer 13 years experience toward maximizing an employer s productivity and profitability.

 

profile of qualifications

 

         integral leader who contributes knowledge of cgmp, iso, fda (cber), and eu requirements, as well as experience implementing 510(k) center software, designing critical organizational requirements, and creating targeted sops.

         ambitious self-starter who is pursuing six sigma black belt and cqa qualifications projected for 2010 completion.

         top performer who plans, prioritizes, and manages multiple tasks within fast-paced, deadline-driven situations.

         excellent communicator who seamlessly interfaces among all levels of business staff and regulatory agencies.

         member of the american society for quality.

 

key areas of expertise

 

regulatory compliance                                             database development                            corrective action plans

policy / procedure development                            team building / training                       client / business relations

organizational process improvement                    strategic analysis / planning                 reports generation / presentations

 

professional synopsis

 

director of regulatory affairs / metrology & validations / quality & risk management

 

         utilized broad scope of industry knowledge to develop, revise, and distribute sops in all areas, including overseeing quality supervisors at multiple locations, creating cber submissions and correspondence, and handling all auditing.

         improved efficiency by initiating a new department for review and approval of all donor center equipment validations.

         expertly reviewed all errors and incidents, managed and evaluated corrective action and preventative action plans, and analyzed risk, along with implementing dmaiic principles and root cause analysis to exception handling.

         ensured compliance with federal, state, international, and customer requirements by evaluating systems and sops, along with creating and maintaining core databases for statistical analysis, adhering with clia / cola regulations within remote locations, and serving as the company s primary point-of-contact with individual state regulators.

         led targeted training / development efforts for employees by creating all programs and instructional documents.

         directed a product compliance department, including reviewing and releasing source plasma shipments, and reviewing mirs and pirs and determination of bpdr requirements.

 

corporate quality manager / database administrator

 

         strategically steered the design and implementation of a new internal electronic system which was instrumental in providing immediate incident reporting, corrective / preventative action planning, follow up, tracking, and trending.

         compiled, analyzed, and presented company annual quality reports, including contributing strong communication skills toward delivering presentations for quality department staff using statistical analysis of incident trends.

         performed audits; completed audit responses for fda, iso, qpp, gha, customers, and regulatory agencies; completed fda error & accident reports and post-donation information reports; and drafted and revised sops.

 

center manager

 

         drove operations growth by recruiting, training, and managing a 24-member team, including identifying key issues, diagnosing causes, and determining corrective actions, as well as initiating new processes for ensuring compliance.

         increased production by 40% while maintaining plasma volume and cost records, and producing detailed reports.

 

education

 

bachelor s degree in psychology & speech communications                                                   lubbock christian university

yyyyyy x. yyyyyy

(xxx-xxx-xxxx • abc@xyz.com

 

 

 

 

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hiring agent name

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dear__________________:

 

i am currently seeking a challenging [ insert job title ] role, and am submitting my resume for your review.

 

i am excited to build a rewarding career with your company, and am confident that my professional abilities can help to achieve your objectives.  i can offer 13 years of solid experience in regulatory compliance, sops / policy development, process improvement, and strategic planning / analysis, and am well-versed in all facets of database development, corrective action plans, and team building / training.  i am also skilled with cgmp, iso, fda (cber), and eu requirements.

 

to complement my background, please note that i am currently pursuing rigorous six sigma black belt and cqa qualifications projected for a 2010 completion.  i also hold a bachelor s degree from lubbock christian university, and am a member of the american society for quality.

 

most recently, as director of regulatory affairs / metrology & validations / quality & risk management for international bioresources, llc, i utilized my broad scope of industry knowledge to develop, revise, and distribute sops in all areas, including overseeing quality supervisors at multiple locations, creating cber submissions and correspondence, and handling all auditing.  within this role, i ensured compliance with federal, state, international, and customer requirements by evaluating systems and sops, along with creating and maintaining core databases for statistical analysis, adhering with clia / cola regulations within remote locations, and serving as the company s primary point-of-contact with individual state regulators.  as this is just a sampling of my job history, please kindly refer to my enclosed resume for additional experience.

 

you will find me to be a results-focused professional who can contribute a track record of organizing complex processes and systems, defining key priorities, and meeting targeted goals.  in addition, i can recruit, develop, and manage teams within fast-paced, deadline-driven environments while streamlining operations processes to increase productivity, efficiency, and quality.  for the sum of these aforementioned reasons, i believe i will prove to be an incredible asset to your company.

 

i look forward to hearing from you, and thank you in advance for your consideration.

 

sincerely,

 

 

 

patrice hauser