Karie Nowak
Fremont,Ohio
Summary
Talented Manager with expert team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.
Overview
9
9
years of professional experience
Work History
Manager Laboratory Services, Analytical Services
NAMSA
08.2022 - Current
- Responsible for managing 50+ associates and $25M annual sales
- Controlled costs to keep business operating within budget and increase profits with record-breaking profit levels (YOY) through effective cross training and resource utilization
- Responsible for new test development through validation and qualification
- Work with Senior Management and Quality Assurance to write, implement and maintain standard operating procedures, laboratory documentation and technical guidelines
- Achieved departmental goals by developing and executing strategic plans and performance metrics
- Lead failures, non-conformances and all Major CAPAs
- Ensured compliance with industry regulations and legal requirements by implementing comprehensive policies and training programs for staff members.
- Set aggressive targets for employees to drive company success and strengthen motivation.
- Used industry expertise, customer service skills and analytical nature to resolve customer concerns and promote loyalty.
- Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
Laboratory Supervisor, Analytical Services
NAMSA
06.2017 - 08.2020
- Supervised laboratory staff and processes while increasing efficiency and lowering budgetary costs by 15%
- Hire and train staff to run analytical testing compliant with ISO accredited QMS
- Implemented the installation and validation of 6 instruments totaling over $2M
- Oversee analytical team efficacy and increased from 60-70% average on-time completion to 80-93%
- Revised and drafted Standard Operating Procedures, Test Methods and Specialty Protocols
- Responsible for coordinating and communicating on project updates with clients to regulatory submission
- Monitor variances, failures, non-conformances and major CAPAs
- Handle all complaints in a timely manner and creating/implementing process improvement changes through the department
- Ensure compliance with current Good Manufacturing Practice regulations, and other associated guidance such as AAMI, ANSI, ISO and USP
- Interact with clients, auditors, inspectors, subcontractors, consultants, and other individuals or departments
- Assist with Cost Estimate Proposals and advise clients on routine technical issues.
- Enhanced laboratory efficiency by streamlining processes and implementing new technologies.
- Reduced turnaround time for test results by optimizing workflows and laboratory procedures.
- Ensured accuracy in testing by maintaining rigorous quality control standards and regularly calibrating equipment.
- Improved staff competency through continuous training programs and performance evaluations.
- Increased productivity with effective resource allocation, maximizing the use of available personnel and equipment.
- Established a safe working environment by enforcing strict adherence to safety protocols and guidelines.
Senior Technical Reviewer, Analytical Services
NAMSA
10.2016 - 06.2017
- Established and ensured schedule and quality commitments are met for clients
- Evaluated, analyzed and interpreted study data and presented in a clear, well-organized scientific report
- Manages internal team members to ensure that client expectations are met
- Developed and lead moderately complex study designs and served as the primary contact for the client, as assigned, and kept the client informed of schedule and any unforeseen events or issues.
- Increased review accuracy by implementing a comprehensive training program for new reviewers.
- Maintained strong attention to detail while reviewing numerous documents daily, ensuring consistent quality and accuracy.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
Technologist, Analytical Services
NAMSA
05.2015 - 10.2016
- Entered and reviewed analytical data in LIMS
- Trained analysts in department
- Perform analytical routine test article/product preparation according to protocol
- Assure testing/test article preparation/product is performed within due dates
- Maintain ancillary records and provide on the job training
- Perform physiochemical testing on test article/products.
- Collaborated with cross-functional teams to develop cutting-edge software solutions, driving business growth.
Pre-Analytic Technologist
Promedica
01.2015 - 05.2015
- Receive and sort specimens in a timely manner
- Registers patients for billing
- Determine whether specimens are efficient for testing ordered
- Run specimens through appropriate machine for specific testing.
Education
Bachelor of Science -
Ohio Dominican University
Columbus, Ohio12.2014
Biology Major -
The Ohio State University
Columbus, Ohio12.2011
Skills
- Strategic Planning
- Contract Management
- Business Development
- Performance Management
- Policy Implementation
- Operations Management
- Staff Development
- Marketing
Job Specific Skills
- Instrumentation: FTIR, GC/MS, HPLC, IC, ICPMS, ICP-OES, UV-Vis
- Supervise ISO 17025 quality control production laboratory
- Maintain an ISO 17025 Accredited Laboratory
- Implement and directed the replacement, installation, and scale up of production chemistry (analytical) on an Inductively Coupled Plasma Mass Spectrometer (ICPMS), a ca. 300K USD project
- Lead non-conformance, complaints and Major CAPAs
- Developed analytical methods for testing including creation of novel analytical testing.
- Manage a team of 50+ chemists, directing training and purchasing activities, in a production environment with sales of >25MM USD
- Proficient in Microsoft Word, Excel, PowerPoint, Access, Outlook; proficient with internet research skills
Certification
Timeline
Manager Laboratory Services, Analytical Services
NAMSA
08.2022 - Current
Laboratory Supervisor, Analytical Services
NAMSA
06.2017 - 08.2020
Senior Technical Reviewer, Analytical Services
NAMSA
10.2016 - 06.2017
Technologist, Analytical Services
NAMSA
05.2015 - 10.2016
Pre-Analytic Technologist
Promedica
01.2015 - 05.2015
Bachelor of Science -
Ohio Dominican University
Biology Major -
The Ohio State University
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