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Kelly Services Data Verification Specialist in Austin, Texas
Kelly is hiring a Data Verification Specialist for one of our medical device clients in Austin, TX.
1 year contract to start
Will start on a M-F 8a-5:30p shift, then potentially move to a 6a-6p shift either on Sun-Tues and every other Wed or Thurs-Sat and every other Wed.
A bachelor degree is required.
Ideal candidates will have at least one year of recent GMP lab experience. Pharmaceutical experience is highly preferred. Chemistry degree is required unless they have demonstrated competency with previous experience in a GMP/Pharma QC
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 also review and develop laboratory documents including standard operating procedures (SOPs), evaluation and installation of new lab equipment, and new testing methodologies.
Essential Duties & Responsibilities:
• Maintain the Quality Laboratories computer systems (e.g. administrator, manage accounts, complete PMs) and ensure cGMP compliance of electronic data.
• Perform the independent data review of testing forms and batch records.
• Responsible for initiating, performing, documenting and approval of laboratory related validations and technology / test method transfers.
• Instrument troubleshooting and maintenance.
• Review and edit laboratory documents including SOPs, batch records and testing forms.
• 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 environment to prevent reoccurring events.
• Provide input on opportunities and issues to management as necessary.
• Perform other related duties as assigned or required.
Knowledge, Skills & Qualifications:
• 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 and project development based on department needs.
• 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.
• Qualification as a Senior Chemistry technician is preferred.
• Working knowledge of IsoTrain, Lean concepts, Lab Investigations and respective corrective preventive action systems (TrackWise / LIR / CAPA) preferred.
Education and Experience:
• Bachelor’s Degree is required: Chemistry, Chemical Science, Engineering, Biology
• Must have 0-3 years’ of experience in a Quality Control role as a chemist, and/or previous experience in data review or peer review in an FDA regulated environment.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)