Lisa Eichler-Johnson Email & Phone Number

Allegan, Michigan

Compendial Affairs:* Significantly develop/expand Compendial Affairs program (Support multiple sites)* Develop SharePoint process to manage Compendial Affairs project workload* Project management oversight for several departments* Compendial Affairs training for multiple locations* Manage Compendial Affairs review teams* Draft commentary proposals as needed* Represent company/industry in multiple external industry working groups* Build relationships across compendial community and increase knowledge in domestic and international compendia* Global oversight for management of compendial content access across corporation* Global point person to disseminate information relating to compendial changes/topics to monitor* Keep up to date regarding significant FDA and ICH changes impacting compendial processes* In 2016 role grew to incorporate more focus on advocacy management, which additionally increased over the following years and led to a title update in 2021, officially adding the advocacy component into the role. *Lead interactions and built opportunities to engage, rather than just take part in interactions with global compendial organizations.*Expand knowledge of global health authority organizations. *Teach colleagues how to respond to items open for comment on the FDA docket and submit comments myself.

Allegan, Mi

Purchased Materials Compliance Chemist (2009 to 2015)* Created Position with management staff* Continual expansion of position/responsibilities/tasks and eventually create new position of Compendial Affairs Process/Project Manager * Ensure Compendial Compliance for Purchased materials arriving to QC Lab (single site support) by managing project teams, drafting of change control etc. * Co-Lead Compendial Changes Review Team for several departments* Manage Creation of/aid in creating Microsoft VBA projects to automate lab processes used by dozens of employees across multiple work groups* Managed and partially automated high volume process flow (several 100 each month) for Certificate of Analysis / Certification of Compliance paperwork for incoming quality receipts to ensure all data met needed requirements* Oversee design of systems/processes for multiple departments to add new compliance projects or resolve issues with existing systems * Oversee design of automated RFT process for quality employees within several departments1st Shift Purchased Material Technician (2007 to 2009)* Testing of pharmaceuticals including mainly: HPLC, FTIR, Specific Rotation, UV-VIS, Particle * cGMP documentation during testing* Review/Release of department testing paperwork* Represent Department on Compendial Review Team/ Compendial Project Work* Support/Manage Change Control Projects for Purchased Materials* Support lab training program as a trainer when needed

Allegan, Michgian

QC Weekend PM Product Group Leader* Approximately 8-10 direct reports* Schedule incoming products* Manage/document potential failure investigations* Manage multi-department process improvement project teams* Testing paperwork review QC 2nd Shift Lead Technician* Schedule incoming materials for testing for different work groups and balance daily release priorities* Training of new shift employees* Support/document OOS investigationsQC 2nd Shift Raw Material Technician* Testing of pharmaceuticals including mainly: HPLC, FTIR, Specific Rotation, UV-VIS, Particle Size, Density, pH, wet chemistry identification testing * Occasional testing of: AA, Impurities, Water/Conductivity, GC * cGMP documentation during testing* Review/Release of department testing paperwork

Portage, Michigan

* Prepare large volume solution and media orders for multiple hallways of microbiology labs* Routine supply ordering for several labs (pipets, reagents, labware etc.) and ensuring supply ordering met budget requirements* Schedule and run autoclave cycles for waste process for group of labs, including for biological hazards* Washing/disposing of labware following testing for group of labs* Set up carts for delivery to different labs with needed testing supplies* Prepare all needed cGMP documents for solution and media preparations* Streak plates to prepare other labs for downstream testing

Master Of Science - Ms, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Bachelor’S Degree, Biological And Biomedical Sciences

Biology, General

Associate’S Degree, Biology, General