Heidi Steele Email & Phone Number

Longmont, Colorado, United States

ccountable for the supervision and management of QC functions through supervisors, specialty analysts, lead analysts• Manage the testing and release of pharmaceutical products, raw materials, intermediates, cleaning, bulk and stability samples on a timely basis.• Responsible for cGMP compliance of laboratory • Assist director in executing laboratory planning, process efficiency • Provide evaluation of the overall validity of the analytical results reported and generate certificate of analysis and review stability reports.• Establish priorities and ensure on time delivery of results for department.• Review and approve technical reports, test methods and procedural documents.• Responsible for maintaining a safe working environment for all laboratory personnel.• Conduct and coordinate laboratory investigations and incident reports, plan and execute CAPA items and change controls through QMS.• Approve and Review Manufacturing Batch records

Longmont, Colorado, United States

Accountable for the supervision and management of QC functions through supervisors, specialty analysts, lead analysts• Manage the testing and release of pharmaceutical products, raw materials, intermediates, cleaning, bulk and stability samples on a timely basis.• Responsible for cGMP compliance of laboratory • Assist director in executing laboratory planning, process efficiency • Provide evaluation of the overall validity of the analytical results reported and generate certificate of analysis and review stability reports.• Establish priorities and ensure on time delivery of results for department.• Review and approve technical reports, test methods and procedural documents.• Responsible for maintaining a safe working environment for all laboratory personnel.• Conduct and coordinate laboratory investigations and incident reports, plan and execute CAPA items and change controls through QMS.• Approve and Review Manufacturing Batch records

Longmont, Colorado

Accountable for the supervision and management of QC functions through supervisors, specialty analysts, lead analysts• Manage the testing and release of pharmaceutical products, raw materials, intermediates, cleaning, bulk and stability samples on a timely basis.• Responsible for cGMP compliance of laboratory • Assist director in executing laboratory planning, process efficiency • Provide evaluation of the overall validity of the analytical results reported and generate certificate of analysis and review stability reports.• Establish priorities and ensure on time delivery of results for department.• Review and approve technical reports, test methods and procedural documents.• Responsible for maintaining a safe working environment for all laboratory personnel.• Conduct and coordinate laboratory investigations and incident reports, plan and execute CAPA items and change controls through QMS.• Approve and Review Manufacturing Batch records

Broomfield, Colorado

As part of the AS&T team, I support critical activities related to facility closure including compendial compliance, deviation support and method transfers. I manage projects which consist of method transfer protocols, executing transfer testing, analyzing analytical data at both sites and writing the final transfer reports. I helped with Method Validation, Triage lab investigations, review SOP's and update as needed. I am an active member on the sites Emergency response team. I am also a certified drug agent (certified to handle and test controlled substances). While in this position, I received training on GC analysis including residual solvents by headspace sampling and other applications.

Broomfield,Co

I lead a team of 9 highly skilled chemist. My team is responsible for 70% of the volume that comes through our finish dosage lab. I was responsible for scheduling my teams daily work as well making sure our ever changing customer needs were met while, preforming testing myself. I am highly skilled in cGMP's, HPLC, uHPLC, dissolution, UV's and currently working with automated technologies in an analytical laboratory. I fully support automation and strive to be proficient at it. Automation is the wave of the feature in quality and reducing human error. I assisted with the update of old methods and procedures as well as SOPs to meet todays quality standards. I supported method validation activities needed from our AS&T group. I did periodic reviews of methods and SOP's. I worked on a design for standard hours to show what a expected days work should look like. This helped improve efficiency across the lab and analyst to analyst with scheduling and expected turn times. This also helped management know our capacity for planning purposes. Along with standard hours, a " role card" for each analytical test per product was designed. This helped with planning standard hours and supporting the reduction of human error. A member of our emergency and spill response team for the site. I am knowledgeable in handling and testing controlled substances. I was in training to become a certified laboratory investigations. I also help management to trouble shoot root causes for investigations. I am proficient in LIMS, empower and trackwise.I am highly motivated to achieve and excel. My passion to do well is reflected in my teams attitude and willingness to help me as a lead succeed.

Broomfield, Co

Quality Control Chemist in QC lab. I became proficient at analytical testing which encompassed Dissolution, Assay, Related Compounds, FTIR, UV/VIs, HPLC, UHPLC, KF moisture titrations and automated dissolution testing. I quickly became a highly valued member of our High Volume, high turn around team with very . I quickly arose as a team leader in the group. I have experience in Instrument maintenance and was an subject matter expert on UHPLC, HPLC and automated dissolution systems. I am also certified to handle and perform testing on controlled substance scheduled III & IV.

I was responsible for daily laboratory services which included Daily Balance Calibrations, Glassware washing, pH meter daily checks, and Pipette washing. I also was responsible monthly and quarterly preventive maintenance on Dissolution Baths, HPLC's and UV/Vis.

Chemistry

Microbiology And Immunology