Kayla Biermeier Email & Phone Number

Professional experience in both quality and production systems allows me to bring unique, cross-functional insight and a comprehensive approach to project planning, training, execution, and problem-solving.Driven by a strong work ethic, I strive to provide quality products and results while maintaining patient-first mentality, seeking continuous improvement opportunities, and promoting a work environment that meets and exceeds industry standards, ethics, and safety.Skillsets:General:- cGMP and GDP compliance- Aseptic technique- Creation and modification of controlled documents (batch records, SOP's, forms, and training documents)- Batch record, logbook, and QC data review- Qualified Trainer (Train the Trainer)- Environmental Control Strategy- Kanban/ Inventory systems- eQMS systems- Sample Management systems (SME)- Use, calibration, and verification of laboratory equipmentQuality Systems:- Lead Investigator (events, deviations, change control, OOS, hypothesis testing, CAPAs, and effectiveness checks)- Investigation and Root Cause Analysis training (40 hours through PathWise)- TrackWise and MasterControl eQMS- Annual Product Reports (APR)- Scheduling and maintaining Contract Laboratory audits in the eQMS- SixSigma (white belt)Quality Control (Microbiology):- MET / MET Suitability Testing (filtration and pour plate methods)- Endotoxin Testing (kinetic chromogenic, MCS, and gel clot methods)- Mycoplasma Testing- Media preparation / Media QC- Environmental and Personnel Monitoring (viable air, non-viable air, contact plates, settling plates, PW / WFI)- Annual Environmental Monitoring ReportscGMP Manufacturing:- Clean room gowning (SME)- Operation within classified production environments (all Grades)- Manual fill finish operation in Grade A / B classified areas (SME)- Bulk filling of product- Chromatography / Tangential Flow Filtration (TFF)- Personalized Vaccine Unit (PVU)- mRNA-based therapeutics- Product inspection, packaging, and labeling- Cleanroom sanitization (SME)- Cross training with Upstream, Downstream, and Solution Preparation manufacturing processesMammalian Cell Culture:- Maintenance of iPSC cell lines- Differentiation of stem cells- Media and solution preparationEnvironmental Health and Safety (EHS):- Safety Committee (Member, secondary department representative)- First Responder Team (Leader)- American Red Cross certification in First Aid and Basic Life Support (most recent recertification: SEP2024)

• 

  Madison Area Technical College

  Biotechnology