Shannon Teeters-Kennedy
Director Of Quality at Bravado Pharmaceuticals, LLC.- Claim this Profile
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Bio
Experience
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Bravado Pharmaceuticals, LLC.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director Of Quality
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May 2022 - Present
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APS Pharmacy
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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QA/QC Manager
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Mar 2021 - Apr 2022
• Responsible for the design, implementation and execution of policies and procedures to ensure that quality standards are met during production. • Promote quality achievement and performance improvement throughout the organization. • Ensure compliance with national and international standards and legislation. • Validate quality processes by establishing product specifications and quality attributes, measuring production, documenting evidence, determining operations and performance qualifications, and writing and updating quality assurance procedures. • Liaise with auditors and ensure the execution of any corrective action. • Identify relevant training needs and deliver training. • Develop preventative maintenance schedule and equipment record logs. • Formulate and manage the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC. • Identify and resolve problems, completes audits, determines system improvements and implement change. • Author/update/review SOPs, work instructions, and policy documents as needed • Investigate complaints and OOS results. • Trained in aseptic gowning and the basics of aseptic technique. • Trained to perform endotoxin testing and microbiological surface and air samples. Show less
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CoreRx, Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Laboratory Training & Investigation Coordinator
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Jan 2020 - Mar 2021
• Design, develop, and maintain course content for a laboratory training program• Conduct learning needs assessments to identify training gaps• Conduct training sessions and supervise trainings performed by qualified trainers• Manage the execution, review and reporting of laboratory investigations• Perform in-depth investigations, including the use of root cause analysis techniques• Communicate with clients as needed for investigations• Compile and track laboratory investigation related metrics• Perform weekly QA audits of the analytical lab facilities• Perform duties as the Chemical Hygiene/Safety Officer for the lab• Perform duties as an Empower (software) Super User • Participate in client and FDA audits Show less
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Senior Scientist/Lead Investigator
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Jan 2018 - Dec 2019
• Managed and led laboratory investigations • Instrumental in significantly reducing the time required to complete and close investigations• Identified and implemented appropriate and effective corrective/preventative actions • Communicated with other departments and with clients about investigations• Mentored other team members• Developed/lead training sessions for the laboratory• Completed KREWE training (Train-the-Trainer program)• Performed duties as the Chemical Hygiene/Safety Officer for the lab• Performed duties as an Empower (software) Super User• Provided a supporting role during FDA audits Show less
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Senior Scientist
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Dec 2016 - Dec 2017
• Managed testing for specific products • Performed analytical testing for pharmaceutical products using a variety of instrumentation• Communicated test plans and results with the other departments and clients• Mentored and trained other team members• Developed/optimized/validated test methods• Wrote/reviewed method validation protocols.• Reviewed analytical testing performed by other analysts
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Xcelience (Acquired by Capsugel)
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Analytical Team Leader
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Dec 2015 - Dec 2016
• Supervised about 15 analysts.• Managed testing for 20-30 clients• Provided administrative management support for the Analytical Department including performance reviews, career development, disciplinary actions, participation in interviews, etc.• Provided technical direction and guidance to department • Resolved technical and administrative issues • Communicated analytical testing progress and results to clients• Communicated with and provided necessary support to other departments to ensure successful and timely completion of projects• Certified trainer for laboratory instrumentation, documentation practices, etc.• Wrote Laboratory Investigation Reports for out-of-specification and out-of-trend results. Show less
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Chemist II
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May 2014 - Dec 2015
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Eurofins Lancaster Laboratories
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United States
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Biotechnology Research
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700 & Above Employee
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Chemist II
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Jul 2013 - Apr 2014
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Franklin College
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Higher Education
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300 - 400 Employee
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Assistant Professor of Chemistry
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Aug 2007 - Jul 2013
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The Ohio State University
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United States
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Higher Education
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700 & Above Employee
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Graduate Reasearch Associate/ Graduate Teaching Assistant
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Jun 2002 - Aug 2007
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Capital University
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United States
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Higher Education
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500 - 600 Employee
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Adjunct Professor of Physics
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Aug 2006 - May 2007
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Ohio Wesleyan University
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United States
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Higher Education
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500 - 600 Employee
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Assistant Professor of Chemistry
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Jan 2006 - May 2006
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Bishop Ready High School
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Columbus, Ohio Area
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Chemistry Teacher
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Dec 1999 - Jun 2002
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Education
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University of Florida
Master's degree, Pharmacy, Forensic Science concentration -
The Ohio State University
Master of Science (MS) and Doctor of Philosophy (Ph.D.), Chemical Physics -
Capital University
Bachelor of Arts (B.A.), Chemistry and Comprehensive Science Education