Karen Bozeman

**** ********* **

Pelham, AL *****

770-***-****

act26n@r.postjobfree.com

Objective: Secure employment in a challenging and rewarding environment, which offers career growth potential.

Availability: March 2016

Employment History:

2011 – 2015, Evonik Corporation, Birmingham, AL:

2012 – 2015, Quality Control Supervisor

Responsible for training, scheduling, payroll, performance evaluation, and career development for staff of eight: (two senior scientists, two scientists, three associate scientists, and one lab technician). Oversight of daily sample testing and data review in support of biomaterials and drug delivery businesses (raw material, production, environmental monitoring, stability testing, and final material release). Ensured that all laboratory testing, instrumentation, and training complied with applicable regulatory requirements (cGMP,GLP, USP, EP, EMA, CP, BP, ASTM, DIN, and FDA). Acted as laboratory representative during client and regulatory audits. Acted as lead investigator and approver of any deviation to quality control procedures, excursions, testing failures, out of specification and out of trend results. Monitored and reported KPI’s to upper management, suggested and implemented corrective and preventive actions to ensure improvements in laboratory compliance and efficiencies.

2012 – Senior Scientist

Acted as North American Project Leader to harmonize analytical test methods with our sister lab in Darmstadt, Germany. This required leading a cross-functional team of quality, technical, business, regulatory and validation representatives to ensure successful international launch of unified biomaterials products. The end-deliverables included procurement, installation and validation of several new laboratory instruments; authoring, reviewing, validating, and implementing several new or modified test methods that met EP/USP/ASTM/CP & DIN requirements; and consistently gave accurate and reproducible results between sites per ANOVA statistical analysis.

2011 – 2012, Contract Scientist

Supported senior scientists in sample testing, data review, chemical inventory maintenance, revision of procedures, technical support to clients, and investigation of out of specification results.

2004 - 2010, BioLife Plasma Services, Hoover, AL:

2008 – 2010, Quality Associate II

Supervise and train assistant auditors, lead and conduct first and second party product and process audits. Prepare audit responses, identify, implement, monitor, and close corrective actions for laboratories and centers. Assist with hosting/coordinating third party audits. Support Validation and Release Supervisors to ensure staff compliance with regulations related to quality of product and employee safety. Train employees and evaluate performance of procedures. Manage change control system. Develop, complete, and review protocols, master validation plans, and validation packages. Compile, maintain, and coordinate reporting of PPTA/epidemiological data.

2005 – 2008, Auditor/Tracking & Trending Specialist

Conduct internal and prepare for external audits by direct observation of lab processes, review of maintenance records, donor charts, validations, employee training records, nonconformance reports, and various lab quality control records.

Initiate SOP change requests to ensure proper performance and improve efficiency of procedures.

Author, validate, and train staff on new or revised SOP’s prior to implementation.

Review and approve validations of testing on new or upgraded equipment and procedures.

Tracking, analysis and reporting of trends in daily quality control data and nonconformance reports. Suggest and implement changes to decrease occurrence of errors in same.

Review and approve final release of laboratory data from Acclaim to DIS.

Assist in training and supervision of quality coordinators as needed.

Maintain competency and certification in review of several testing areas, as indicated in lab coordinator position previously held.

2004 – 2005, Lab Coordinator

Ensure and enforce CLIA, cGMP, GLP, GDP compliance as required by FDA for all testing of viral and other significant chemistries on plasma and serum products prior to release to recipients.

2003 – 2004, Quality Control Manager, Titan Coatings, Bessemer, AL

Formulation adjustment and troubleshooting of plant scale products to customer specifications (color, cure, viscosity, specific gravity, solids, VOC, pH, drawdown & spray DFT) for alkyd and waterborne industrial paint coatings.

Supervision and training of plant operators to ensure compliance with SOP’s in proper formulation adjustment and reporting of specifications to customers.

Maintenance and archival of SOP’s, lot information for raw and finished products, standards and equipment according to ISO 9002 standards.

Prepare and host external customer and ISO audits.

1997 – 2003, Kemira Chemicals, Marietta, GA:

2001 – 2003, Sr. Development Chemist/Project Leader

Supervision and training of research assistants in all experimental phases. Project Leader: Led first approved long-term project dev. idea submitted & approved by Sr. Mgmt. under new ISO standards.

Design of Experiments, supervision of performance, and analysis of results for product development and improvement.

2003---Silver Level Award ($500K+ net profit) New Product Implementation---Combined alkaline and acidic furnish drainage and retention aid in papermaking.

2000 - 2001, Development Chemist---Colloidal Silica/Polymer Synthesis

Lab formulation, pilot scale synthesis, quality assurance methods and SOP development, instrument installation, QA and production staff training and supervision, plant scale implementation for various colloidal silica, water and organic soluble polymer products.

1997 – 2000, Analytical Chemist

Deformulation of competitive products, support of R&D chemists, independent design of methods/SOP’s/Spreadsheets for product analysis, training and supervision of new chemists and technicians. Proficient in GPC, GC, FTIR, AA, X-Ray Fluorescence, and UV-Vis instrumentation. Extensive experience in various wet chemistry methods including VOC, Soxhlet extraction, KF titration, NVM, gravimetric titration, and others. Responsible for issuing reports on analytical results. Responsible for maintenance, calibration, and statistical QC of previously mentioned instrumentation. Ensure compliance and monitor and report to FDA, Federal and local EPA, and OSHA regulatory agencies as required.

1996 – 1997, Environmental Chemist, Hygeia Laboratories, Marietta, GA

Analysis and reporting of results by EPA methods for environmental contaminants including: TOC, ammonia, cyanide, heavy metals, phosphorus, flashpoint, total solids, pH, alkalinity, and sulfites. Matrices tested include: soil, paint, water and air filters.

1995 – 1997, Lab & Teaching Assistant, Kennesaw State University, Kennesaw, GA

Freshman through senior level chemistry labs. Duties included tutoring of students in lab and lecture material, instruction and maintenance of instrumentation including: UV-Vis, NMR, GC, FTIR, bomb calorimeter, MP apparatus, pH meters, and others. Testing of new lab procedures, preparation of standards, supervision of students in labs to ensure compliance with SOP’s and safety policies.

Academic History: Kennesaw State University 1994 – 1998

Bachelor of Science Degree in Chemistry

Minor: Biology

GPA: 3.6

Extracurricular Involvement:

American Chemical Society Student Affiliate Member 1994 – 1997

Vice President 1996 – 1997

Secretary 1995 – 1996

Kennesaw State University Ambassador 1995 – 1997

Special Recognition:

Phi Lambda Upsilon Inductee (1999)

Outstanding Chemistry Student (1998)

Outstanding Service to a Campus Organization (1996)

Golden Key Inductee (1996)

Other Relevant Experience:

Proficient in all Microsoft Office Applications. DMAIC trained. RABQSA Certified Lead Auditor.

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