~ Eager to contribute a Degree in Biology as well as keen interests in environmental science toward supporting a dynamic company in optimizing bottom-line performance. ~

 

 

         Adept in quality engineering and management, QC laboratory testing, staff/team leadership, and skillfully communicating with personnel across all levels of an organization.

         Strong interests in conservation compliance and enforcement.

         Exemplary blend of prioritization, troubleshooting, decision-making, forecasting, and analytical thinking skills.  

         Able to precisely define goals, uncover challenges, propose modifications, and drive solution implementation to achieve measurable and immediate process improvements.

• Strong scientific, analytical, report writing, and conceptual skills.

         Flexible, enthusiastic, and willing to relocate.

 

 

BS Degree in Biology, Ball State University, Muncie, IN, 2000

                                                                                                                                                                 

 

Baxter Pharmaceutical Solutions LLC, Bloomington, IN, 2005 to Present

Quality Project Analyst

         Steadily advanced through a series of promotions to current role driving QA Management approval of compliance documents (including SISPQ and non-SISSPQ impacting exception reports and validation/qualification protocols and summaries), composing audit responses, and partnering with Maintenance and Sterility Assurance to achieve facility improvements.  

         Proficiently guide and assist Quality Line Operations Associates to ensure business continuity and immediately resolve problems.

         Championed introduction of visual board for exception reports to slash cycle time of non-SISPQ impacting exceptions from an average of 40 days to less than 15 days.

         Diligently compile and present crucial metric data to senior management utilizing Microsoft Excel and PowerPoint applications, A3 reports, and cause-mapping diagrams.

 

Theoris, Inc., Indianapolis, IN, 2004 to 2005

Validation Specialist

         Successfully completed consulting assignment focusing on authoring validation documentation such as Specifications, Qualifications (IQ, OQ, PQ), and Traceability Matrixes following GAMP 4 and 21 CFR 820. 

         Spearheaded planning and development of training program for new electronic manufacturing execution system. 

 

Continued

 

Yyyyyy x. yyyyyy ~ Page 2 of 2

 

Professional Experience continued

 

Kelly Scientific Resources, Indianapolis, IN, 2003 to 2004

Analytical Chemist

         Resourcefully established and documented new analytical methods for cleaning validations in a 21 CFR 210 and 211 regulated environment. 

         Leveraged significant critical thinking abilities to evaluate scientific equipment and provided training to other analysts, exhibiting a strong team player work approach.

 

Indiana Protein Technologies (ivax), Greenwood, IN, 2000 to 2003

Associate Scientist                             

         Wrote, reviewed and edited extensive paperwork such as SOPs, Forms, Policies, and investigations to achieve and ensure GMP compliance for start-up company. 

         Conducted research on new equipment to ensure 21 CFR Part 11 compliance, set up test methods, and trained other scientists in software use and proper procedures. 

         Exercised strong expertise in lab techniques to conduct a broad scope of analytical testing including HPLC, Electrophoresis, Western Blot, LAL, and TOC.  

         Utilized environmental monitoring equipment including air samplers, particle counters, and agar plates to accurately trend data and verified rooms stayed within USP (United States Pharmacopeias)  limits; assessed, characterized and recorded contaminates. 

         Employed a constant commitment to cost control in evaluating suppliers and streamlining ordering and receiving process, subsequently saving company thousands of dollars.

 

 

Certified Quality Engineer (CQE), ASQ

 

BPS Lean Academy, Baxter Pharmaceutical Solutions

 

cGMP and Audit Training, Compliance Insight  

 

Aseptic Processing Guidance, PDA    

 

EU Annex 1, David Begg and Associates

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date

 

 

Hiring Agent Name

Title

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I am currently seeking a challenging career opportunity in the Environmental Science arena and am submitting my resume for your review.  In advance, thank you for your time and consideration.

 

As demonstrated, I possess a Bachelor s degree in Biology, outstanding engineering experience, exemplary talents in conducting research, and keen interests in conservation compliance.  Furthermore, my extensive analytical background and accomplishments would be a great asset in the environmental science field. 

 

I am certain that you will find me to be a highly motivated professional committed to supporting you in achieving your objectives through dedication and initiative. I am extremely confident that I could be a valuable asset to <insert name of organization>, and look forward to interviewing with you in the near future. 

 

Sincerely,

 

 

 

Yyyyyy x. yyyyyy