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Quality Assurance Management

Location:
Warsaw, Indiana, 46580, United States
Posted:
June 08, 2011
Email:
tuyqkj@r.postjobfree.com
Contact Info:
*************************@*****.***


Shelly Keesee
(574)***-****
tuyqkj@r.postjobfree.com

Summary of Qualifications:

• 16 + years : technical and regulatory documentation writing and QC
• 7 years of quality assurance experience
• Exceptional written/verbal communication and project management skills
• Areas of therapeutic experience include diabetes, cardiovascular, infectious disease, oncology, CNS, GI, dermatology, respiratory, hematology, endocrinology, genitourinary, acute/ chronic pain and anti-inflammatory.

Summary of Experience:

Supervisory, Consulting and Training
• Created and conducted training on SOPs, specs, test methods and instrumentation for analytical laboratories.
• Hired, trained and supervised writing department of seven employees for Biotech CRO.
• Developed an ISO 14001 system in its entirety and trained 300+ employees including upper management for automotive parts facility.

Documentation
• HACCP, ISO 9002, ISO 13485 and ISO 14001 documentation and implementation
• Well versed in GMP, GLP, GCP, FDA, CFR11, 30 CFR, API and TPD requirements and documentation.
• AS400, MSWorks, MSExcel, MSWord, Lotus, dBase, WordPerfect, Publisher, PowerPoint, Visio, BPCS, JDEdwards, Documentum, Agile, Minitab and Medstat (statistical) , Help and Manual(Online help documentation development)
• CTR summaries, CSRs (preclinical and Phases I-IV), protocols, Addenda and Amendments, Synopsis, Risk Profiles IBs, NDA, INDA, SAPs, SOPs, manuscripts for journal submission, Test methods and Specifications, Validation and Stability reports, Master site and Batch documents, Material release. Sampling plan development, Certificates of Analysis, Fabrication guidelines, scientific handouts and presentation slides/outline/notes, abstracts and presentation posters for abstracts and Computer Systems Validation of lab and automation systems.
• Database management and document tracking. Archiving and file retrieval. Technology transfer and harmonization of documentation between international facilities.
• Developed product brochures, and handled tradeshow exhibits and media relations for environmental Bio Amendments and Bio Augmentation systems.
• Acted as Senior technical writer for pre-clinical and clinical protocols, validation and study reports for clients in Europe, Japan, USA and Canada.

Project Management
• Alliance project experience and advanced alliance management training completed
• Project timeline management, co-ordination of multiple departments with respect to information gathering and technical content for multiple teams, in multiple therapeutic areas for all stages of preclinical and clinical development.
• In charge of coordinating teams for clean up of large-scale diesel fuel spills, including onsite personnel, MOE, and HAZMAT.

Quality Management
• Internal auditing set-up. QS 9000 documentation management. GAP Analysis. Performance metrics. Training Systems development and implementation.
• Quality Control: Ensure all reports and accompanying raw data are correct, GLP compliant and acceptable according to SOPs and protocols prior to submission.
• Followed-up on corrective action or answer and follow-up scientific questions indicated on QAU report audits, including tracking of audits to ensure timely completion.
• Tracked audit findings to address process problems or training issues.
• Interacted with department staff to acquire information for report writing and auditing purposes and present QAU information to staff regarding deficiencies and areas of improvement.
• Performed corrective action or answer inquires indicated in sponsor review of data/report.
• Performed monthly laboratory audits.
• Corresponded with QA Managers of outside contracts with regards to Master site and batch documents. Maintained Master product files for submission. Verified validation documents and audits and controlled such documents. Product launch documentation management. Wrote SOPs to ensure procedural compliance with guidelines and regulations. Responsible for analytical testing of all consumer and pharmaceutical products. Testing encompassed all dosage forms. Specialized in controlled substances testing. Responsible for material handling of all incoming product for retain and laboratory testing, assignment of testing protocol and log maintenance.

Other
• Experience in pharmaceuticals, bioanalytical , finance, customer service, sales and automotive
• Experience in minerals/ores, food chemistry and microbiology
• Calibration and usage of most types of laboratory equipment
• Learn quickly and adapt easily to new tasks and environments
• Strong research skills
• Strong desire to learn and achieve

Work History:

Technical Writer (Petroleum Industry) Berkley Imperial, Houston, TX 01/2011-03/2011

Editing and technical writing of submissions to BOEMRE for high pressure well designs.

Technical Writer (Validation)(Medtronic) InfoTree Services Inc, Plymouth, MI
O6/2009-12/2010
Development and revision of SOPs for Validation department. Review of all validation protocols prior to and after execution. Engineering co-coordinator duties when required. Assisted with CAPA’s and internal audits of VMP. Validation of CNC equipment. Development of power point training slides. Building of SharePoint for procurement dept. Acted as technical writing expert.

Freelance Writer (Regulatory)(Pharma) Professional Medical Writers, LLC
2008 to Current
Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR summaries for multiple product clients at all phases of development.) Responsible for project management.

Medical Writer (Regulatory)(Lilly) i3Statprobe, Indianapolis, IN 2007 to 2008

Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR summaries for multiple product platform teams at all phases of development.) Responsible for project management and training of new employees.

Technical Writer (IT infrastructure)(Bristol) Aetea, Evansville, IN 2007

Responsible for development of an online interactive instruction and training manual for the department

Regulatory Writer (Regulatory)(Lilly) InVentiv Clinical Solutions, Indianapolis, IN 2005 to 2007

Responsible for the development of various types of regulatory documentation (protocols, CSRs, IBs, IPCDs and CTR summaries for multiple product platform teams at all phases of development.) Responsible for project management and training of new employees.

Scientific Communications Associate (Regulatory) MedFocus, Indianapolis, IN 2003 to 2004

Medical writer responsible for development of protocols, statistical analysis plans, addenda and amendments for same, synopsis, risk profiles and other relevant documentation for Phase 3 clinical trials. Alliance project experience and advanced alliance management training completed.

Computer Systems Validation Technical Writer Volt Services, Indianapolis, IN 2003

Technical Writer for computer systems validation of lab and automation systems for large multi-national pharmaceutical company. Project timeline management, co-ordination of multiple departments with respect to information gathering and technical content.

Recruiting and Consulting (Phama/Biotech) Vipertechnical Services, Toronto, ON 2001-2002

Owner

Quality Assurance – ISO Simcoe Parts Service Inc., Alliston, ON 2001 to 2002

Team leader and technical writer. Development (writing) and implementation of ISO 14001. Internal auditing set-up. QS 9000 documentation management. GAP Analysis. Performance metrics. Training program and database development and conducting training seminars for all levels. Health and safety related to HAZMAT procedures. In charge of coordinating clean up of large scale diesel fuel spills occurring on site. Reporting of spills and emissions to Ministry of the Environment. Facilities auditing. Ordering of supplies for Environmental Emergency Planning. Co-ordination liaison with Honda of Canada Manufacturing with respect to programs and timelines of project.

Technical Writer Canatech Environmental, Barrie, ON 2001 to 2002

Tradeshows and sales calls for micronutrients, Bio Amendments and Bio Augmentation systems. Correspondence with Agriculture Canada regarding new products legislation. Day to day management of office duties, AR/AP, administration. Chemical testing and product development. Handled development of product brochures, exhibits and media relations.

Technical Information Specialist Novartis Pharmaceutical, Whitby, ON 2000

Acted as technical writer preparing test methods, protocols, specifications, validation and stability reports for new and existing products. Database management and document tracking. Archiving and file retrieval. Technology transfer and harmonization of documentation between international facilities.

Supervisor Bioanalytical Documentation (Regulatory) MAXXAM Analytics Inc., Mississauga, ON 1999 to 2000

Selected, interviewed and hired all Bioanalytical documentation personnel. Prepared internal and external job postings.
Trained staff in appropriate technical writing skills. Prioritized all administrative duties. Overall management of and delegation of priorities and projects to departmental staff.
Responsible performance reviews. Collected and summarized information for departmental tax credit reports. Laboratory audits monthly. Technical writing guidance and training. Literature searches and delegation of the same. Tracking of all scheduled deadlines and status of all reports and projects. Acted as Senior technical writer for pre-clinical and clinical protocols, validation and study reports for clients in Europe, Japan, USA and Canada. Ensured all reports and accompanying raw data are correct, GLP compliant and acceptable according to SOPs and protocols prior to submission to SD for review. Interpreted and accepted data prior to reporting. Optimization of report templates for validation and studies. Integrated & assessed client reporting requirements
Follow-up on corrective action or answer and follow-up scientific questions indicated on QAU report audits, including tracking of audits to ensure timely completion.
Perform corrective action or answer inquires indicated in sponsor review of data/report
Preparation of validation protocols and amendments as required.
Tracking of audit findings to address process problems or training issues.
Improved systems for tracking long term stability assays, organizing files and forms, tracking and file management.
In conjunction with client/technicians/scientists/study directors/manager/QAU, set target dates for assay, QAd data and report completion.

Quality Operations Co-coordinator/ Chemist SmithKline Beecham, Oakville, ON 1998 to 1999

Responsible for development of training manual for QO department
Work on special projects with QO Projects Coordinator. Correspondence with QA Managers of outside contracts with regards to Master site and batch documents. Maintenance of Master product files for submission. Verification of validation documents and audits and control of such documents. Product launch documentation management. Writing SOPs to ensure procedural compliance with guidelines and regulations. Responsible for analytical testing of all consumer and pharma products. Testing encompassed all dosage forms. Specialized in controlled substances testing. Responsible for material handling of all incoming product for retain and laboratory testing, assignment of testing protocol and log maintenance. Material release. Sampling plan development.

Quality Assurance Assistant Astra Pharma, Mississauga, ON 1996 to 1997

Responsible for revision of existing specifications and test methods in accordance with FDA, TPP and USP guidelines. Development of new specifications and test methods required for the Quality Control lab. Preparation of documentation and official Certificates of Analysis for export submission qualification. Product and raw material handling and coordination of export for same.

Education:

1991-1994 Loyalist College of Applied Arts and Technology, Belleville, ON
Graduated with a diploma in Chemical Engineering Technology

1988 Loyalist College of Applied Arts and Technology, Belleville, ON
Print Journalism