Description
FLSA Status - Exempt
The primary responsibility of the Data Verification Specialist is to ensure the Chemical Quality (CQ) laboratory is in compliance with cGMP technical requirements, training, data review, pre and post sterile product testing, investigational testing and investigations, and completion of area related projects. The position is responsible for providing the independent data review of testing forms and batch records generated within the applicable laboratories. The Specialist may assist in the review and development of laboratory documents including standard operating procedures (SOPs), evaluation and installation of new lab equipment, and new testing methodologies.
• Ensure cGMP compliance of electronic data.
• Perform the independent data review of testing forms and batch records.
• May assist in instrument troubleshooting and maintenance.
• Actively support Operational Excellence (Lean / Six Sigma) activities and be accountable for sustainability and continued development in the work area.
• Incorporate best practices from Operational Excellence, industry practices into the laboratory review environment to prevent reoccurring events.
• Provide input on opportunities and issues to management as necessary.
• Perform other related duties as assigned or required.
• Thorough knowledge of the various instruments with demonstrated expertise on the technical instrumentation used in the lab, specifically HPLC and GC including: validation, theory, preventative maintenance, and trouble shooting. Individual must have knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada).
• Must have led and successfully completed projects.
• Demonstrate project abilities in proficiency evaluation and certification programs including knowledge in USP terminology and requirements and has exhibited the ability to apply standard principles, methods, and techniques in resolving technical problems.
• Must have good interpersonal and communication skills to successfully perform all aspects of training, scheduling and project management.
• The incumbent must be able to work effectively with all levels of individuals within the organization (interdepartmental, cross functional, Research and Development) and have exhibited a high level of personal maturity and professional judgment.
• Must be self-directed and demonstrate an ability to work independently in prioritizing data review.
• Possess strong time management and effective writing skills, highly organized and be a critical thinker.
• Must have strong technical and/or leadership skills with good analytical and problem solving skills.
• Demonstrate a high degree of initiative and flexibility.
• Must be able to multi-task and work in an ever-changing fast-paced environment.
• Working knowledge of training software, Lean concepts, Lab Investigations and respective corrective preventive action implementation preferred.
• Must be at least 18 years of age
• Bachelor's Degree is required: Chemistry, Chemical Science, Engineering, Biology
• Must have 2+ years of experience in a Quality Control role as a chemist or a minimum of 6 months experience in data verification in an FDA regulated environment.
• Office and laboratory environment.
• Must be able to occasionally move and lift objects of up to 25 pounds
• Typically requires travel less than 5% of the time
ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
What We Do
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Since IV therapy is our only business, meeting your IV needs with quality products and consistent supply is our only concern. We are 100% focused on bringing you intuitive, patient-centric IV products and services that provide meaningful clinical differentiation, consistent innovation, and superior value. We design our products to work within your existing workflows to minimize disruption and maximize the time you spend with patients.
Together, we help forge the human and emotional connections that enhance clinical experience and are the essence of outstanding quality of care.
For more than three decades, we have been dedicated to a singular purpose—improving the safety and efficiency of IV therapy. With the acquisition of Hospira Infusion Systems from Pfizer in 2017, we became the only company to focus exclusively on IV therapy across the continuum of care.
Our focus allows us to bring you:
> Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
> The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
> IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
> Significant US IV solutions manufacturing and supply capabilities.
