Ann Johnson Email & Phone Number

Raleigh, North Carolina, United States

North Carolina, United States

• Developed and established competency-based training program, resulting in the trainee becoming competent and confident in the specific skill after 100% of the training events.• Created work instruction template based on human error assessment and reduction technique (HEART), which decreased the likelihood of errors occurring for equipment operation. This reduced equipment malfunction and loss of product and increased process efficiency with a 90% success rate.• Developed and delivered a train the trainer program for task trainers, which set up trainers to successfully deliver training that resulted in behavior change. The program included initial blended training and evaluations and support to ensure task trainers consistently and successfully delivered task training every time.• Designed and implemented a coaching certification program and team-building activities using DiSC behavior model, resulting in 98% increase in improved working relationships.• Underpinned the manufacturing certification process through the creation and execution of technical theory manuals, tests, and aligned task training. This certification provided advanced theory knowledge, enabling manufacturing technicians to make advanced decisions, and creating a career pathway for advancement.• Restructured analytical training to include multiple formats (e-learning, video, Vyond animation) to transfer theory knowledge in combination with in-person task training. This method made training available in smaller sections which increased the transfer of knowledge from 50%-70% to 100%. • Created and edited videos demonstrating the use of analytical and manufacturing equipment to increase understanding of the equipment. This was especially important for new equipment such as a single-use centrifuge, enabling technicians to operate the new equipment successfully.• Facilitated Kepner-Tregoe problem-solving analysis and risk assessments, delivering greater quality by design.

North Carolina, United States

Coordinated and facilitated GMP, compliance and regulatory issues with both internal and external clients.• Represented Quality to internal and external stakeholders (clients), ensuring successful project outcomes. This included but was not limited to ensuring batch records were approved in time for production to start on time, all technicians were trained and ready to perform the process, completed batch records were reviewed to result in a released product.

North Carolina, United States

Established standards for equipment, computer, cleaning, process, and method validation. Successfully ensured all appropriate operating procedures were updated to include standards to guarantee quality within the three organizational biotech manufacturing sites.• Facilitated comprehensive cross-training for the QA validation support group in an understanding of validation standards, which improved the QA review of protocols and reports by focusing on technical review.

North Carolina, United States

Established standards for equipment, computer, cleaning, process, and method validation. Successfully ensured all appropriate operating procedures were updated to include standards to guarantee quality within the three organizational biotech manufacturing sites.• Facilitated comprehensive cross-training for the QA validation support group in an understanding of validation standards, which improved the QA review of protocols and reports by focusing on technical review.

North Carolina, United States

Managed a team of cleaning validation technicians and contractors to develop, execute and document cleaning validation for multiple projects.

Covance

•Created the Cleaning Program and standards•Wrote and executed Cleaning Validation and Changeover protocols•Wrote and executed Process Validation protocols•Coordinated and managed team to perform sampling and documentation

Supervised technicians, developed Batch Records, and reviewed documentation for purification processes.

Corning Bio Rtp, Nc

Set up equipment, documentation, purchasing, and validation for startup company.

Education record

Bs, Biology

Activities and Societies: VP Biology Club