Tanya L. Keller, M.S., CQA

Experience

• 

  Charles River Laboratories

  Jan 2006 - Nov 2010

  Necropsy Supervisor

  Significant achievements: Authored new SOP’s, including Photobiology and confirmation of in-life clinical observations. Direct interaction with Foundation for Biomedical Research tour groups to facilitate discussion of the importance of animal research and to foster interest in careers involving research animals. Began career with this company as an entry level technician and received five promotions including Blood coordinator and Team Leader before advancement to supervisor.Vast experience in animal welfare, animal handling and restraint, rodent and rabbit anatomy, necropsy techniques, gross tissue changes and gross lesion description, shipping; and data collection, correction, and review.Managed 4 direct reports – responsible for their supervision, professional development, training, promotion, performance reviews; and study preparation, execution, and study reports.Supervised 13 technicians – responsible for overseeing all study activities, performance of study procedures, and training. Свернуть

• 

  Merck

  Jan 2012 - Apr 2014

  Manager, Operations Sterile Liquids

  Dual responsibilities in Sterile Filling and Sterile InspectionSupervise processing and inspection of sterile vaccines and hourly employees to attain required stock.Experience in a sterile pharmaceutical manufacturing environment that is domestically and internationally compliant with regulatory agencies requirements. Maintain and train hourly employees to perform various job functions.Work daily in Class A aseptic environment.Experience working with paper and electronic batch records, PAS-X, and SAP software.Work directly with Quality, deviation management, and environmental monitoring departments.Use lean six sigma and Toyota® manufacturing model to analyze and implement manufacturing process changes. Свернуть

• 

  Medical Components, Inc.

  Jun 2014 - Mar 2016

  Manager of Quality Systems, Auditing, QA, QC, and Document Control departments. QC/QA department management. Preparation and approval of procedures, documentation review, training of direct reports on QC staff, Sterilization Quality Policies and Procedures, improvement of Quality Control policies, and Quality Assurance.Helped the company transition from a device company to a pharmaceutical combination product manufacturer.

  • Sr. QA Manager

    Dec 2014 - Mar 2016

  • QC/QA Manager

    Jun 2014 - Dec 2014
• 

  Sanofi

  Mar 2016 - now

  Evaluate and provide QA recommendations on all products, systems, and issues that may be affected by regulatory and cGMP requirements and ensure adherence to Quality Management System requirements (including 21 CFR: 211, Part 11, Part 4, & 600). Provide support, input, recommendations, and guidance regarding Change Control, Document Management, Deviation (non-conformance/OOS), corrective/preventive actions (CAPA), & continuous improvement to areas of oversight: Quality Control (including Stability), Technical Services, ITS, Site Quality Systems (including Supplier Quality, Quality Risk Management, CMO Management, & Incoming Quality), Operations Planning, Supply Chain, SAP Systems, Regulatory Affairs, & Training. • Function at a level of autonomy and able to make decisions and interpretations within defined requirements• Complete Minor and Major incident deviation/non-conformance investigations, root cause analysis, & final recommended batch disposition in response to any unexpected events encountered during manufacturing, testing, or out-of-specification lab results• Provide oversight, guidance, and training to QA team regarding CAPA, Deviation/OOS, Change Control, and Document management• Participate in project teams involved with the facilities, processes, instruments, and equipment for manufacturing & testing of vaccines• Ensure a constant state of inspection readiness and all audit observations are addressed• Support FDA and international regulatory bodies during site inspections• Represent QA on key forums and teams to evaluate and provide QA recommendations on products, systems, and issues Свернуть Evaluate and provide QA recommendations on all products, systems, and issues that may be affected by regulatory and cGMP requirements and ensure adherence to Quality Management System requirements (including 21 CFR: 211, Part 11, Part 4, & 600). Oversight of QC testing (validated and USP), Incoming Quality (including third-party/Supplier Change Notification), Batch Release, Analytical Sciences (R&D), Seed Manufacturing (Live viral and bacterial), & Technical Services (Maintenance, Metrology, Engineering & Automation) in classified and unclassified areas including BSL2+.• Direct interaction with FDA and international health authorities during site inspections• Mock FDA / internal audits of testing & production• SME for select external audits of suppliers• Regulatory compliance for licensed and unlicensed products (all phases) through:o Product stability programo Deviation/non-conformance/OOS investigations, root cause analysis, & product dispositiono Document management - specifications, protocols/reports (DOE and investigational testing), standard work instructions (SWI), standard operating procedures (SOP)o CAPA & Change Control managemento Determination of appropriate disinfection, sanitation, sporicidal, and contamination controls • Qualified trainer for Quality processes: deviations, document control, CAPA, change control• Project management and process improvement evaluation and implementation• Collaborate with other QA groups, Regulatory, R&D, QV, Production, and other departments to meet deadlines Significant achievements:• Oct2018 to Apr2019 – QA for Formulation, Filling, Inspection, & Packaging (FFIP) Job Exchange. • Investigator Education Program – 4-week comprehensive Deviation/CAPA training program. Свернуть

  • Senior Quality Compliance Manager - Vaccine

    May 2022 - now

  • QA Compliance Manager US

    Mar 2016 - May 2022