Ashley Lee
Regulatory Affairs Specialist at ELITE One Source Nutritional Services- Claim this Profile
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Bio
Experience
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ELITE One Source Nutritional Services
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs Specialist
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Jan 2021 - Present
Responsible for maintaining certification programs such as NSF, Gluten Free, USP, Organic, Kosher, Halal, and Vegan/Vegetarian. Manage regulatory compliance within the Food & Dietary Supplement industry. Provide direction to the quality team to ensure processes and procedures align with regulatory and certification program guidelines. Coordinate the Food Defense and Food Safety teams to develop, implement, and maintain our Food Defense and Food Safety Plans. Responsible to oversee the Installation/Operation Qualifications (IOQs) and Validations as required for processes, facility, and analytical methods, ect.. As well as help to manage compliance and certification audits.
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GSK
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Value Stream Manufacturing Operator
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Apr 2018 - Dec 2020
Responsible for the fermentation process in the manufacturing of the adjuvant MPL and following GMP/GDP procedures. Participate in training of new hires and developing professional relationships with my team. Work with individuals of diverse backgrounds to develop validation protocols. Participate in writing and reviewing final reports. Responsible for the fermentation process in the manufacturing of the adjuvant MPL and following GMP/GDP procedures. Participate in training of new hires and developing professional relationships with my team. Work with individuals of diverse backgrounds to develop validation protocols. Participate in writing and reviewing final reports.
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Blue Marble Biomaterials (Acquired)
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United States
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Biotechnology Research
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1 - 100 Employee
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Senior Analytical Scientist/Quality Manager
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Oct 2015 - Mar 2018
Responsible for working with a diverse team to develop ideas for large scale manufacturing. Managed and worked with a small quality team that ensured the delivery of the highest quality product to market through analytical testing and the development of a Quality Management System. Responsible for collaborating with the Training Coordinator to ensure we established an effective training program within the company. Mentored my team to help them achieve their development objectives. Responsible for working with a diverse team to develop ideas for large scale manufacturing. Managed and worked with a small quality team that ensured the delivery of the highest quality product to market through analytical testing and the development of a Quality Management System. Responsible for collaborating with the Training Coordinator to ensure we established an effective training program within the company. Mentored my team to help them achieve their development objectives.
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Mission Mountain Laboratories
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Food and Beverage Services
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1 - 100 Employee
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Analytical Chemist/Quality Control Officer
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Aug 2013 - Oct 2015
Analyzed the quality of food, water, and nutraceuticals for vitamin contents, minerals, and heavy metals. Responsible for interacting with customers to answer questions regarding test results and developing time lines for returning test results. Implemented ISO 17025 standards which included writing and maintaining Quality Control Manual and revising standard operating procedures. Responsible for working with team to develop and implement training procedures. Analyzed the quality of food, water, and nutraceuticals for vitamin contents, minerals, and heavy metals. Responsible for interacting with customers to answer questions regarding test results and developing time lines for returning test results. Implemented ISO 17025 standards which included writing and maintaining Quality Control Manual and revising standard operating procedures. Responsible for working with team to develop and implement training procedures.
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Blue Marble Biomaterials
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United States
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Biotechnology Research
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1 - 100 Employee
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Research Assistant/Intern
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Feb 2012 - Jan 2014
Responsible for performing research and development scale experiments. Collaborated with research team on experiment designs. Prepared accurate and concise reports and drew conclusions regarding experiment results. Had the opportunity to develop a research project that resulted in a presentation at Montana State University during the governor’s award for innovation as part of a scholarship program. Responsible for performing research and development scale experiments. Collaborated with research team on experiment designs. Prepared accurate and concise reports and drew conclusions regarding experiment results. Had the opportunity to develop a research project that resulted in a presentation at Montana State University during the governor’s award for innovation as part of a scholarship program.
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Certified Pharmacy Technician
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May 2011 - Aug 2011
Properly filled and dispensed prescriptions. Received and stored incoming inventory, verified quantities against invoices, and checked for outdated medications. Performed clerical tasks, such as filing, answering phones, and operating cash register, maintaining prescription records, or composing letters. Properly filled and dispensed prescriptions. Received and stored incoming inventory, verified quantities against invoices, and checked for outdated medications. Performed clerical tasks, such as filing, answering phones, and operating cash register, maintaining prescription records, or composing letters.
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Education
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University of Montana
Bachelor's degree, Forensic Chemistry -
Montana Tech of the University of Montana
Chemistry, 3.8