Quality Control Support Analyst IV

Grifols Inc. San Diego , CA 92140

Posted 2 weeks ago

Quality Control Support Analyst IV

Location:

CA-San Diego, US

Contract Type: Regular Full-Time

Area: Quality

Req Id: 112697

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.

A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.

Summary

The primary job function of the QC Support Analyst IV is to test and release raw materials, sub-assemblies or finished goods.

Primary Responsibilites:

  • Performs routine testing related to Procleix products including master lot release testing, performance testing, and analytical testing using GMP/GLP practices.

  • Performs routine testing using instrumentation such as HPLC, MALDI-TOF, FTIR, UV-Vis, Ion Chromatography.

  • Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limits.

  • Participate in QC Method Qualifications

  • Responsible for revising QC documents (SOPs, QSs)

  • Participates in Lab Investigations and Out of Specification investigations.

  • May act as the primary QC trainer in specific test methods

  • May be responsible for writing non-conformance investigations with the assistance of a QC Specialist or Supervisor

  • May lead a small team for continuous improvement projects

  • Responsible for maintaining product and QC material inventories.

  • Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials.

  • Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed.

  • Responsible for completing training in a timely manner and maintaining the records.

Skills and Experience:

  • 2-4 years of experience

  • Minimum 2 years of experience with HPLC

  • Working knowledge of GMP/GLP.

  • Intermediate computer skills.

  • Some technical writing skills.

  • Problem Solving

  • Attention to detail.

EEO Minorities/Females/Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

Learn more about Grifols


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VIEW JOBS 3/13/2020 12:00:00 AM 2020-06-11T00:00 QC Support Analyst IV Location: CA-San Diego, US Contract Type: Regular Full-Time Area: Quality Req Id: 102769 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. A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations. Summary The primary job function of the QC Support analyst 4 is to test and release raw materials, sub-assemblies or finished goods. Primary Responsibilities for Role * Performs routine testing including release testing, performance testing, analytical testing, bioburden testing, environmental monitoring using GMP/GLP practices. * Performs data analysis and results interpretations comparing to specifications, validity criteria, alert limits. * Participate in QC Method Qualifications * Responsible for revising QC documents (SOPs, QSs) * Participates in Lab Investigations and Out of Specification investigations. * May act as the primary QC trainer in specific test methods * May be responsible for writing non-conformance investigations with the assistance of a QC Specialist or Supervisor * May lead a small team for continuous improvement projects * Responsible for maintaining product and QC material inventories. * Responsible for the maintenance and cleanliness of the laboratory, stocking shelves/drawers with testing materials. * Responsible for the maintenance and cleanliness of equipment, calibrating or submitting items for calibration as needed. * Responsible for completing training in a timely manner and maintaining the records. Knowledge, Skills, and Abilities * Working knowledge of GMP/GLP. * Intermediate computer skills. * Some technical writing skills. * Problem Solving * Attention to detail. Education B.A. or B.S. in a bioligical science or chemistry Experience 2-4 years Occupational Demands lift up to 25 lbs EEO Minorities/Females/Disability/Veterans Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg Learn more about Grifols Grifols Inc. San Diego CA

Quality Control Support Analyst IV

Grifols Inc.