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Quality Analyst I 1st Shift

Location: 

TX-Austin, US

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  138066

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.

With the world's largest network of plasma donation centers, Grifols, through its Bioscience Division, is a leading producer of essential plasma-derived medicines for the treatment of rare, chronic, and sometimes life-threatening conditions. To help ensure a reliable and consistent source of plasmaderived medicines worldwide, we have an integrated production process that begins with plasma collection and continues through fractionation and purification at our three facilities located in Spain (Barcelona) and the United States (Clayton, North Carolina, and Los Angeles, California). Key products include immunoglobulins, alpha-1 antitrypsin, albumin, clotting factors and specialty products.

Quality Analyst I 1st Shift M-F 8:30 AM - 5:00 PM

 

Summary: Under direct supervision, support the quality system by collecting, analyzing, and disseminating performance data used for quality control monitoring, root cause analysis, laboratory performance assessments, and continuous improvement activities.

 

Primary responsibilities for role:

  • Collect quality related performance data from production and laboratory support activities.
  • Perform standard data reduction techniques to assess data, and provide weekly and monthly reports to laboratory management.
  • Assist laboratory management in gathering, compiling, and analyzing data for investigations, studies, or other special projects.
  • Write simple error investigation reports, including determining remedial actions, analyzing and determining error risk and impact, analyzing and determining root cause, and proposing corrective and preventative actions.
  • Work on problems of moderate scope where analysis and situations of data requires a review of a variety of factors.
  • Conduct investigation meetings of applicable laboratory staff members to apply quality analytical tools to determine root cause of laboratory errors and proposed corrective and preventative actions.
  • Communicate performance data with laboratory internal and external customers.
  • Assist in internal and external audits.
  • Accurately complete detailed documentation as required by established procedures and good documentation practices regulations.
  • Effectively communicate with personnel from various departments building productive internal/external working relationships, and escalate issues and identified quality related performance data trends to Quality Management.
     
    Knowledge, Skills, and Abilities
  • A intermediate level of understanding of Microsoft Excel required, including writing basic formulae to extract, reduce, analyze, format, and graph large groups of data. Light statistical analysis background necessary such as population distribution, regression analysis, confidence intervals, linearity, outlier detection, and quality control charting.  Knowledge of Microsoft PowerPoint also required. Knowledge of CAPA system and root cause investigation tools preferred.
     
    Education
  • Bachelor’s degree required. Science, mathematics, or quality related field preferred.
     
    Experience
  • Typically requires a minimum of 1 year of practical experience working as a quality assurance professional in a cGMP regulated environment.

 

EEO/Minorities/Females/Disability/Veterans

Location: NORTH AMERICA : USA : TX-Austin:USHOME - Home Address 

 

Learn more about Grifols