Responsible for manufacturing site Compliance via administration of Internal Audit program, deploying trainings and consulting internally and across the Kite network to align practices with an evolving regulatory landscape.

Responsible for management of the site's internal audit program and all inspection-readiness and GxP inspection related activities.

Planning and administration of site Internal Audit schedule, as well as coordination of audit tools, documents, records and personnel involved in audit process. Direct responsibility for support of global and domestic inspections at manufacturing site, including tracking of inspections records and messaging of key site achievements. Responsible for development and administering training materials to support successful internal audits, inspections and site responses to observations that may occur.

Continuing work in the research, analysis and application of domestic, international and industry standards for the production and distribution of biologics in reproductive and stem cell therapy. Directly responsible for federal, state and institutional licensing requirements. Additional responsibilities include vendor management, supporting internal audits, preparing for and supporting inspections and process optimization. Strong communication, organization and interpersonal skills have lead to expanded responsibilities and opportunities as the company continues to evolve from California Cryobank to Generate Life Sciences.

The Quality Assurance position is a collaborative role where I partner with all internal stakeholders on traditional CAPA management as well as process improvement and compliance. This role has expanded to support our Regulatory Affairs team, including our internal audit & inspection processes, licensing & accreditation requirements and vendor management. While the role is primarily focused on internal processes, the position also requires an ability to interface with state and federal agencies as well as industry-specific auditors.

This position was at the nexus of outside testing facilities, and internal laboratory, sales and accounting teams, and was responsible for oversight & management of client records. This role entailed communicating processing results to clients & global commercial partners on a daily & weekly basis, with special attention to the timely communication of non-conforming results. With both internal and external stakeholders, this position required an ability to effectively communicate and negotiate with a wide spectrum of people, as well as a strong emphasis on organization, detail and follow-through.

Coordination of training, on-boarding and HR advisory support to client groups totaling up to ~100 employees throughout the US & Canada. Also focused on the integration of AmniSure International following its acquisition by QIAGEN in 2012, especially communication of new policies, processes and programs.

Sole HR point-of-contact for fast growing medical device company. Responsible for full life cycle recruitment in US, development and communication of AmniSure employer brand, coordination of on-boarding and ongoing trainings as well as HR advisory to senior management. Continued support of European and Russian subsidiaries in training and staffing efforts. As Executive Assistant, also responsible for support to two senior managers, including calendar management, planning multi-leg global itineraries and meeting coordination. Special projects I worked on during this time include: translation of presentations and documents from English to Spanish; coordination & execution of first Employee Engagement survey; point of contact for clinical trial based in Medellín, Colombia.

Sole HR point-of-contact for growing medical device company. Responsible for full life cycle recruitment in US and supported staffing and training efforts in European and Russian subsidiary offices. Coordination of all on-boarding for new hires, including maintaining specialized training schedules and procurement of appropriate training resources. As Executive Assistant, also responsible for support to two senior managers, including calendar management, planning multi-leg global itineraries and meeting coordination.Special projects I worked on during this time include: coordinating and executing the first-ever Company Wide Meeting for all of AmniSure US and our subsidiary partners in Europe & Russia, including materials, event space, event planning and transportation; working with Marketing team to plan special events for KOLs in MFM and OB/GYN;

Primary administrative support at small but fast-growing medical device company based in Harvard Square (and, later, in downtown Boston). Worked with every department to meet the many needs of this entrepreneurial venture. Primary responsibilities include maintenance of office and supplies, filing, data entry, and coordinating conference attendance (including reserving materials for booths, shipping collateral material, reserving travel and lodging, securing visas if necessary for travel outside of the US, etc).

Developed and taught unique curriculum for two semesters of an introductory writing course at Boston College aimed at First Year (Freshman) students. This course was primarily designed to teach First Year students the conventions of college writing as they are applicable to different disciplines. As an instructor, I met with all 15-20 students twice a week for classes, and held mandatory 1:1 meetings with students every other week. These courses were taught concurrently as I pursued my Master's degree and worked as an Administrative Assistant at AmniSure International.Responsible all aspects of course, including: creation of syllabus, unique lesson plans & writing exercises, developing capacity for pre-writing activities in students (including brainstorming, outlining, etc), fostering dialogue with students about writing and submission of final grades.

Sole administrative support for contract cable installation company. Primary responsibilities include collecting and filing daily worksheets, data entry and bi-weekly review of payroll report to ensure harmony between worksheets, data and payout. Other responsibilities include filing of HR-related paperwork, light coordination of installations, reception and processing job applicants.