Stephanie Bartke Email & Phone Number

Loveland, Colorado, United States

-Leads and manages interdisciplinary project teams related to the operational processes (facilities strategy, warehouse transfers, process development, manufacturing transfers from R&D to mfg and between facilities/projects, of veterinary in-house diagnostics)-Responsible for day-to-day execution of projects, ensuring on-time delivery within.

Boulder, Colorado, United States

-Develop and implement risk-based and flexible approach to QA, which will ensure that trial participants and data generated are safeguarded in compliance with applicable regulatory requirements and best practice.-Develop, implement and maintain QMS and CAPA systems.-Interface with and act as a liaison to sponsors and study coordinators, and take the lead.

Fort Collins, Colorado, United States

• Project Management Experience
• NPD/LCM, focus on development of analytical methods to support multiple projects at dif phases of maturity, clinical trials; facilitate method transfer to CROs or internal QC
• Create and present weekly/monthly project status, data reports to various stakeholders
• Develop project charters, roadmaps and milestones, led key stakeholder engagement and accountability
• Negotiate agreements/contracts; Manage vendors/CROs and all studies and SOW… Show more Project Management Experience
• Negotiate agreements/contracts; Manage vendors/CROs and all studies and SOW outsourced

United States

• Provide a leadership role for analytical development; supervise the development of appropriate assays for testing and release of pharmaceutical drug products, raw materials, and stability samples, and facilitate.
• Manage and create regulatory documents for FDA submissions; final approver for AD documents for ANDA filings, validation protocols/reports, investigations/DCAs, test methods, and company procedures
• Evaluate analytical data for validity and… Show more
• Evaluate analytical data for validity and ensure that all operations and functions (including the laboratory) are in full FDA, ICH, GMP and/or GLP compliance; and that staff is properly trained
• Participate in audits (as needed) and directly interact with potential marketing partners, regulatory agencies, and contract labs
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results Show less

• Independently, with little supervision, develop and validate analytical methods to current ICH, USP, and FDA guidelines
• Perform routine sample analyses of formulation, drug, and product samples in support of GLP and R&D stability protocols
• Write and review technical reports, summaries, protocols, test methods, and SOPs, in accordance to government regulations
• Perform equipment troubleshooting, maintenance, and repairs
• Serve as a resource for other analysts, and provide… Show more
• Serve as a resource for other analysts, and provide guidance and training of routine testing and method development

• Performed finished product, in-process, bulk, stability, and raw material testing using in-house methods and USP testing
• Member of the instrument team; conducted maintenance (including annuals and quarterlies), calibrations, and troubleshooting steps on various equipment, with a solid focus on HPLC
• Member of safety and training team; trained coworkers on new methods, lab techniques, and HPLC qualifications
• Completed method transfers and worked closely with analytical… Show more
• Completed method transfers and worked closely with analytical development to troubleshoot, properly execute tests, and develop methods to meet the needs of the QC department
• Facilitated lab investigations and generated data for validations and OOS/OOT studies Show less

• Familiarized with the basic needs and guidelines of a laboratory setting while reinforcing previous knowledge of pharmacology and physiology; recognized groups of drugs, their mechanisms, and clinically relevant side.
• Acquired basic lab techniques, prepared/analyzed lab samples; ran in-house blood work, cytology, and cultures
• Maintained appropriate disposal protocols for hazardous materials; Sustained sanitation/nosocomial protocols for the facility
• Created and… Show more
• Created and maintained all appropriate facility and medical records and logs in compliance with federal regulatory guidelines (e.g. radiography, surgery, anesthesia, laboratory, controlled substances) Show less

Brookfield, Connecticut

Started and completed an education connection internship, which resulted in a permanent part-time position. Left on excellent terms to pursue an education at CSU with the offer of a full-time position upon return to CT. Remained an employee throughout college when returned for summer vacation.

New Fairfield, Connecticut

Summer job only