ALICIA MASKELL
Kansas City,MO
Summary
Diligent and highly self-motivated Sterility Assurance Consultant with 13 years of experience in GMP, Regulatory Compliance, Manufacturing Operations, Project Management, Process Improvement and Quality Assurance in the human and animal health industries. Expertise in driving efficiency improvement, implementing standardized work processes, ensuring regulatory compliance, managing document control, overseeing validation processes, and providing effective team leadership. Proven track record of delivering exceptional results and successfully leading
teams and projects to achieve desired outcomes.
Overview
12
12
years of professional experience
Work History
Sterility Assurance Consultant
Elanco
Elwood, KS
12.2023 - Current
- Consulted the site on aseptic and cleaning validation, efficacy studies and contamination control strategy
- Developed and owned the site sterility plan and the associated workstream improvements
- Consulted the capital project team on Annex 1 interpretations and drove gap assessments to ensure compliance
- Created a "Back to Basics Program" to restructure training and development plans for operators, including on the job training program
- Process mapped high risk manufacturing processes and made changes to reduce error and waste
- Created and managed sterility related SOPs, Work Instructions, Investigation Reports, CAPA's & Deviations
- Aided in the creation of site wide Establishment 196 strategy documents to align on best practices & drive improvements
Senior Specialist, Quality and Compliance
Merck Animal Health
Remote-DE
04.2020 - 12.2023
- Project Manager for all ongoing compliance and regulatory update projects, ensuring initiation, coordination, progress and metric tracking all through execution and sustainment
- Develop and maintain project plans, while tracking progress against targets, CapEx and OpEx budgets and escalation management
- Schedule and coordinate project team meetings (status updates, tier meetings, over site steering committee & company Hoshin updates)
- Led the execution and implementation of Annex 1 EU Regulation Requirement and CCS Strategy
- Led the development and implementation of a USDA integrated product information system for tracking annual outline reviews of documents (local documents and external suppliers)
- Provide training and coaching to team and site personnel to support project goals
- Aided in the development of new standard procedures, work instructions, and training materials
- Ensure gaps are assessed per internal procedures, including requirements for regulatory notification
- Built systems to ensure follow-up and sustainment of projects, CAPA's, Root Cause Investigations, best practices, validation and qualification management, process and aseptic validation, in addition to audit findings.
Associate Improvement Engineer
Merck Animal Health
Ames, IA
09.2018 - 04.2020
- Developed and implemented a project management system throughout the Ames site and shared the knowledge with other sites to create a standard approach for project execution
- Trained and educated the site on project management basics, the roles, and how it relates to the business goals
- Created a culture of problem solvers/project leads who used PM and KATA tools to drive improvements and changes within their areas
- Led value stream and process map activities to identify improvements/projects that would hit a productivity improvement target for the year
- Managed the projects selected during the VSM and process map activities to ensure the projects hit their target condition, on time, within scope and budget and were sustained once implemented
- Participated in the regional Hoshin and business planning events and served as an advocate to ensure alignment between the region and the site activities
- Created a template and lead quarterly metric reviews which included each departments performance including project adherence.
Lead Technician Formulation and Filling
Merck Animal Health
Ames, IA
01.2017 - 09.2018
- Standardized process steps and established standard work which improved delivery of product from 60% on time to 100% on a consistent basis
- Decreased product lead time from 10 weeks to 6 weeks
- Re-designed antigen freezer inventory to create a more efficient picking system
- This decreased this task time from 3 hours to 1 hour per day
- Modified SOP's and batch records to ensure compliance with the USDA and sterility of the product which decreased sterility fails by 40%.
Cell Culture/Electroporation Supervisor
Harrisvacccines
Ames, IA
09.2015 - 01.2017
- Re-developed the cell schedule to increase cell production two fold
- Doubled the number of EP's per bottle
- Managed cell schedule to meet company demand
- Increased cell production from 600 EP's per day to 1,000 EP's per day, with no additional staffing
- Optimized the Electroporation process, by creating standard process steps to enhance the process flow and ensure 1,000 Ep's were completed in the time allowed.
Immunotherapeutic Production Associate II
NewLink Genetics
Ames, IA
10.2012 - 08.2015
- Maintained, grew and harvested a variety of cell lines for vaccine production
- Performed aseptic manipulations and passed media fills in a GMP regulated facility
- Collaborated with management in developing plans for new cell lines
- Gowning qualified and understand classified airflow through environmental monitoring.
Education
Bachelors - Biology
Morningside College
05.2012
Skills
- Project Management
- Experience leading value stream and process maps
- Critical thinking and problem solving
- Diverse in ways of working to motivate and inspire teams to achieve common goals
- Documentation Life Cycle Management
- Qualification Management & Risk Assessments
- Change Control, RFT, RCI and Quality Systems
- Adaptable leader & Effective communicator
- Consistently approached by upper management to create solutions for under performing departments
- Detail oriented with excellent time management skills
- Knowledge and Understanding of USDA, FDA & EU regulations
- Strong background in Good Manufacturing Practices, Aseptic Technique and OTJ Training
Details
11425 N Bristol Ave Kansas City MO, 64150, United States
alicianeal919@gmail.com
515-979-9210
Additional Qualifications
- SEDP Assignment Montes Claros, Brazil, 08/2019, 04/2020, I was selected for a global 6 month assignment, as a candidate of the Skills Expertise and Development Program. The program is supported by the Large Molecule VP of operations. The scope of my assignment was to participate in the execution of a new Clostridium Manufacturing Facility. More specifically, my role was to manage and lead improvement projects. A few of those projects included creating a Single-Use technology white paper to educate the local regulatory agency and site on the benefits of the technology, implement prepackaged, sterile bottles to the filling department, and evaluate the media used in the production process. I also served as the communication link between supporting teams and the project team to ensure projects were executed on time, and within scope. The completion of these projects were crucial to the success of the new facility.
- WLP- Woman's Leadership Program, Cornell University/Merck, 03/2022, 06/2022, Nomination only program designed to enable woman to recognize and seize strategic career opportunities by developing critical capabilities and confidence while contributing and shaping the core objectives of the organization. - Identify personal leadership strengths with a focus on accelerating professional growth - Recognize opportunities to take courageous action - Concepts to enhance negotiation skills, influence, and persuasion - Leadership presence and the art of effective story telling - Characteristics of leaders who foster inclusion, belonging, and engagement - How to enlist sponsors and influential advocates to support personal growth and business goals
Timeline
Sterility Assurance Consultant
Elanco
12.2023 - Current
Senior Specialist, Quality and Compliance
Merck Animal Health
04.2020 - 12.2023
Associate Improvement Engineer
Merck Animal Health
09.2018 - 04.2020
Lead Technician Formulation and Filling
Merck Animal Health
01.2017 - 09.2018
Cell Culture/Electroporation Supervisor
Harrisvacccines
09.2015 - 01.2017
Immunotherapeutic Production Associate II
NewLink Genetics
10.2012 - 08.2015
Bachelors - Biology
Morningside College