Ashley Malchow
Johnstown,CO
Summary
Multi-talented Senior Executive knowledgeable about quality, operations and personnel management. Successful at stepping into diverse positions and making immediate positive contributions. Focused on optimizing operations and motivating employees while establishing market dominance. Persistent leader eager to lead and grow organizations. Skilled in strategic planning, problem-solving, and communication with good understanding of business principles, project management and team leadership. Collaborative with relentless work ethic.
Overview
18
18
years of professional experience
Work History
Sr. Vice President- Corporate Quality & Safety
Microbac Laboratories Inc.
01.2022 - Current
- Responsibilities as in the Sr. Director-Corporate Quality role
- Oversee the Environmental Health and Safety of Microbac’s Laboratories
- Part of the Senior Executive Team of Microbac Laboratories
Sr. Director- Corporate Quality
Microbac Laboratories Inc.
01.2019 - 12.2022
- Company Reorganization effective in December 2018 led to this Corporate Leadership Role with the responsibilities over all of Microbac’s Quality Systems as follows:
- Oversee and ensure the development, implementation and training of effective quality systems in all three lines of business (environmental, food/nutrition and life science)
- Develop and implement Quality Management System (QMS) software companywide to be able to increase efficiencies and oversee quality at each laboratory location
- Develop and lead a team of functional quality Directors for each line of business
- Act as technical resource and final authority in all matters of data quality
- Perform data and systems audits and perform special audits as deemed necessary by client inquiries etc.
- Monitor new regulations and ensure compliance with the current version
- Overall responsibility for Proficiency Testing for the company
- Monitor laboratory’s compliance with the reference methods, SOPs, and agency specific requirements
- Assist in identification of systematic problems within the laboratory
- Perform root cause analysis investigations in response to audit findings, client complaints, training needs assessments, data recall events etc.
- Ensure the quality of data from each laboratory by monthly reporting of each location’s acceptance level of quality metrics (KPIs)
Director-Food & Nutrition
Microbac Laboratories Inc.
09.2017 - 12.2018
- Company Reorganization effective in September 2017 led to this Corporate Leadership Role with the responsibilities over five of Microbac’s Food & Nutrition Laboratories as follows:
- Collaborate with other Director’s to ensure standardization of Microbac’s SOP’s & Quality Systems across the company
- Ensure the facility and staff incorporate GLP’s in all food laboratory areas and operations
- Ensure the technical oversight and profitability of multiple food laboratories
- Ensure staffing levels are appropriate which may include hiring, coaching, performance assessments and termination of employees
- Ensure the technical competency of all food laboratory personnel.
- Ensure the quality of data from each food laboratory
Corporate Director of Microbiology
Microbac Laboratories Inc.
02.2017 - 09.2017
- Working under the Vice President of Quality, the Corporate Director of Microbiology aligning within the Quality organization is a Corporate leader as the technical resource for the network of food and environmental microbiology laboratories (~14) within Microbac Laboratories that held the following responsibilities:
- Spearhead initiatives that propel Microbac to the forefront of the industry within the realm of commercial testing laboratory groups worldwide in areas related to Microbiology
- Ensure Microbac is recognized and prepared for coming changes in, and updates to, requirements related to the regulatory bodies that affect the industries in which Microbac Laboratories works
- Contribute to the growth of Microbac through application of knowledge and expertise, in addition to professional networking, specific to the clients of Microbac Laboratories and the industry as a whole
- Oversee compliance of appropriate methods and reporting across Microbac to ensure acceptable practices are followed across the company
- Develop ideas and methods related to microbiology that provided a competitive advantage to offer customers
- Spearhead the planning and implementation of technical and quality initiatives that lead to new capabilities needed by customers
- Participate, and be visible in, technical societies at a local and national level
- Stay current on activities, requirements, and technology related to microbiology and provide clients with technical assistance and consulting as needed
- Participate in creating and delivering communications up and down the organization to support technical and quality efforts throughout the entire company
- Determine, develop and implement best practices throughout Microbac
- Ensure all laboratories are in compliance with various accreditation standards and meets all regulatory requirements.
- Evaluate and develop methods, technologies and staff to ensure Microbac is adequately positioned to handle the demands of the industry
Assistant Managing Director
Microbac Laboratories Inc.
03.2016 - 02.2017
- Working under direct authority of the Division Managing Director the Assistant Managing Director aids in the overall management of the division
- These responsibilities included:
- Management of day-to-day coordination of resources and personnel for all departments of the division
- Determination of financial performance of the business; assisting in forecasting of revenue, operational costs and profits
- Assessment of staffing needs and work distribution between departments as appropriate
- Approval of equipment and supplies for all departments to ensure smooth operation of the business
- Act as Managing Director in all aspects while MD is out of the office
- Collect and analyze data relating to business performance to provide accurate assessment of business performance ongoing and to review and advise MD, this includes the following: Lab supplies and consumables, purchasing of equipment for special projects, overtime tracking, fixed costs including staff salaries, electricity, building lease and maintenance costs
- Assist in Business Development activities including proposal creation and project execution
- Simultaneously continue as acting Technical Director of Microbiology providing support to local Boulder Microbiology Department Staff as well as assist on Corporate proposals and initiatives
Technical Director, Microbiology
Microbac Laboratories Inc.
07.2015 - 03.2016
- Technical authority of the Microbiology Laboratory unit within Microbac Laboratories Boulder Division with the following responsibilities:
- Oversee the development and validation of new methods and all non-routine work/projects.
- Ensure the laboratory is fully compliant with all regulatory, accreditation, certification and/or licensing requirements (ISO/IEC 17025:2005 A2LA Accredited Laboratory) and that the data generated in the laboratory is reliable and of the highest quality.
- Provide strong, positive leadership to the personnel within department
- Manage staff development through technical guidance and support
- Review internal and customer data for accuracy and approve/send reports.
- Oversee daily operation of laboratory in conjunction with Laboratory Supervisor.
- Define minimum level of qualifications, experience and skills necessary for positions within the assigned unit and works with laboratory leadership and staff to ensure adequate training, guidance and direction is provided, ensuring all staff have the demonstrated ability to perform assigned analyses.
- Ensure proper documentation and staff training records are maintained.
- Ensure instrumentation is calibrated and functioning properly; conducts and/or schedules equipment repair and routine maintenance as needed.
- Evaluate the need to use subcontractors for analyses not performed within the laboratory unit.
- Manage the financial and business aspects of department by developing annual revenue goals and striving to achieve established benchmarks
- Assist the Quality Assurance Officer with QA/QC audits, investigations and corrective actions.
- Interpret technical results and communicate capabilities of the laboratory to current and prospective clients.
- Work collaboratively with QA and Laboratory Leadership to execute or address internal investigations, non-conformances, corrective actions, audit deviations or out of control analyses.
Microbiology Department Manager
Microbac Laboratories Inc.
07.2013 - 07.2015
- Manage the daily operation of the Microbiology Department both technically and administratively by providing the following:
- Strong, positive leadership to the personnel within department
- Managing staff development and training
- Managing departmental certifications and accreditations (ISO/IEC 17025:2005 A2LA Accredited Laboratory) in conjunction with Quality Assurance Officer
- Ensuring quality of work completed and reported, meets or exceeds predetermined quality standards
- Proactively identifying preventive actions while diligently determining root causes and implementing corrective actions
- Managing the financial and business aspects of department by developing annual revenue goals and striving to achieve established benchmarks
- Contributing to senior-level decision making by actively participating as a member of the management team and promoting team building within the overall laboratory
- Developing and enhancing skills and knowledge by keeping well informed and current on issues and new technologies that may impact the company and its clients
- Providing superior customer service
- Overseeing fungal resistance project management by providing expertise and guidance
- Planning and executing critical shelf life/challenge studies in conjunction with Corporate Microbiology
Associate Microbiologist
ConAgra Foods Corporate Microbiology Lab
01.2010 - 07.2013
- Engaged staff member in GLP, BSL2, Certified ISO 17025 food laboratory processing environmental monitoring program samples, R&D project samples, ingredients and finished product samples from various production facility locations
- Leader of Quality Control program within laboratory
- Member of RCA/CAR and Preventive Action Team
- Member of Laboratory Excellence Team that audited plant laboratories, (methods standardization and document organization across 25 locations)
- Responsible for planning/executing over 25 critical applied research projects such as shelf life, challenge and validation studies
- Collected and analyzed data to prepare graphs/charts in order to write and finalize reports for research projects
- Engaged in Laboratory Environmental Monitoring activities (tracking and maintenance of sterile environment in prevention of cross contamination of samples)
- Key contact for LIMS used to prepare and issue reports for plants and research and development (customer service focused)
- Team member in development of new LIMS system for Corporate wide implementation
- Purchasing agent for laboratory supplies and office supplies
- Change Leader for new IT systems such as WebEx and Jabber for laboratories
- Trained new corporate laboratory employees and plant laboratory personnel on procedures and documentation
Microbiology Laboratory Technician I & II
ConAgra Foods Corporate Microbiology Lab
06.2006 - 01.2010
- Engaged staff member in GLP, BSL2, Certified ISO 17025 food laboratory processing environmental monitoring program samples, R&D project samples, ingredients and finished product samples from various production facility locations
- Media preparation, quality control of media preparation
- Biohazardous waste disposal
- Cleaning glassware and various laboratory equipment
Education
Bachelor Degree - Biochemistry, Cell and Molecular Biology
Drake University
01.2006
Skills
- Strategic and Executive Leadership
- Policies and Procedures Development and Management
- Operational Excellence
- KPI Tracking
- Process Improvement
- Corporate Presentations
- Program Oversight
- Analytical and Critical Thinker
- Effective Communicator
- Strategic business planning
- People Management & Development
- Cross-Functional Collaboration
- Change Management
Continuousprofessionaldevelopment
- Microbac L.E.A.D.E.R training course- Crucial Conversations 2019
- Daily Reading on Leadership Skills, Food Safety News, U.S. Food and Drug Administration and Lab Manager
- Soft Skill training courses (10) through Fred Pryor Seminars, 2013-2015
- Root Cause Analysis and Corrective Action Training with Kenneth Stoub from Group Seven Laboratory Services, 2012
Affiliations
- National Environmental Health Association, HACCP Manager Certified, 2013
- International Association of Food Protection, 2013
- Institute of Food Technologists, Professional Member, 2013
- A2LA Accreditation Council Member, 2016
- ASQ- Professional Member, 2022
Professional Highlights
Extremely analytical, organized and detailed oriented individual with experience in third party laboratory operations, quality assurance and applied research activities. Proven ability to manage and execute in all facets of a busy laboratory environment. Managed microbiology department resulting in 2 million dollars in annual sales-140% increase in sales in 2016 compared to 2013. Additionally, oversaw five divisions of business equating to approximately 6 million dollars in sales. Implemented Intellect QMS software companywide to digitize and advance our technology and efficiencies around quality management systems. Experience in managing, mentoring and coaching up to 10 direct employees, 20 employees indirectly through Corporate Quality Organization. Broad knowledge in FDA, USDA, Dairy, USP and Compendium Methods. Passion for auditing quality systems (AOAC ISO/IEC 17025:2017 and TNI 2016), standard operating procedures and standardizing methods and workflows for ultimate efficiency.
Timeline
Sr. Vice President- Corporate Quality & Safety
Microbac Laboratories Inc.
01.2022 - Current
Sr. Director- Corporate Quality
Microbac Laboratories Inc.
01.2019 - 12.2022
Director-Food & Nutrition
Microbac Laboratories Inc.
09.2017 - 12.2018
Corporate Director of Microbiology
Microbac Laboratories Inc.
02.2017 - 09.2017
Assistant Managing Director
Microbac Laboratories Inc.
03.2016 - 02.2017
Technical Director, Microbiology
Microbac Laboratories Inc.
07.2015 - 03.2016
Microbiology Department Manager
Microbac Laboratories Inc.
07.2013 - 07.2015
Associate Microbiologist
ConAgra Foods Corporate Microbiology Lab
01.2010 - 07.2013
Microbiology Laboratory Technician I & II
ConAgra Foods Corporate Microbiology Lab
06.2006 - 01.2010
Bachelor Degree - Biochemistry, Cell and Molecular Biology
Drake University
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