Sarah VanValkenburg, MS, ASQ CQA

Design, develop and deliver content for 3 pharmaceutical quality assurance graduate level courses. course#1: 21CFR210 & 211 regulations course#2: 21CFR820 regulations course#3: Quality Audit/Regulatory Inspection As of Spring 2023, instruction and individual mentorship has been provided to over 260 graduate students in at least one of the 3 courses listed above.

Performed Gap Analysis and developed path forward to implement and execute an Internal Audit Program. Responsible for preparation, hosting and followup of customer audits. Developed, launched and managed New Hire GMP Training Program & performed site-wide biannual GMP Refresher Training.

On assignment project under consent decree conditions. Executed ADDIE training model to prepare and approve GMP training materials for individual SOP procedural training and training program modules. Worked with SMEs to help develop training materials across all functional areas.

Responsible for all aspects of building and managing a GMP Training Program for a commercial medical device manufacturing facility of 200+ personnel including new hire onboarding and annual GMP/ISO Training Program, ADDIE Program, establishment and currency of training curriculums, processing and management of controlled training documentation, implementation of Training Effectiveness measurements and management of staff. Most notable improvement to the program was the design and project management of a custom-built, validated, excel training database to upgrade manual paper-based training system to an electronic platform.

Quality Assurance Unit in a Commercial Manufaturing Facility for a topical, pharmaceutical dosage form.

Managed R&D analytical method transfer and project management of about a dozen Phase III stability studies at contract laboratories for solid oral, solution/suspension and Intra-muscular dosage forms, including commerical products Abilify & Glucophage. QA position included release of clinical supplies (labels, containers, raw materials, bulk batch, and finished clinical kits) and mock pre-approval audits at contract testing labs.

Performed analytical laboratory testing of raw materials, containers and closures, and final solid oral dosage form drug product, including commerical product Lipitor.