Operations Test Associate

SGS_JOB_2450

Scientific
 California
Lab Experience
GMP/GLP
ERP
LIMS
or QSR

Contract - 06 Months

Location : San Diego CA The Operations Test Associate candidate will be responsible for performing QC release testing and analysis of raw materials, in-process, and finished goods for the Molecular Diagnostics Division. The candidate will be responsible for understanding and executing testing on multiple assay platforms in a cGMP environment to ensure timely release of products.

Job Responsibilities:

  • The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned below as reasonably required by business needs.
  • Performs routine testing using GMP/GLP practices.
  • The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned below as reasonably required by business needs.
  • Performs data analysis and results interpretations comparing to protocol-defined specifications, validity criteria, and alert limits.
  • May perform microbiology testing and activities for the QC Micro team.
  • May perform pH and/or HPLC testing for the QC Analytical team.
  • 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.
  • Participates in Laboratory Investigations for Invalid assays and Out-of-Specifications results.
  • Prepares documents for storage in our document management system and manages original data files.
  • Performs routine testing using GMP/GLP practices.
  • Performs data analysis and results interpretations comparing to protocol-defined specifications, validity criteria, and alert limits.
  • May perform microbiology testing and activities for the QC Micro team.
  • May perform pH and/or HPLC testing for the QC Analytical team.
  • 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.
  • Participates in Laboratory Investigations for Invalid assays and Out-of-Specifications results.
  • Prepares documents for storage in our document management system and manages original data files.
  • The incumbent may be asked to perform other function-related activities in addition to the responsibilities mentioned below as reasonably required by business needs.
  • Performs routine testing using GMP/GLP practices.
  • Performs data analysis and results interpretations comparing to protocol-defined specifications, validity criteria, and alert limits.
  • May perform microbiology testing and activities for the QC Micro team.
  • May perform pH and/or HPLC testing for the QC Analytical team.
  • 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.
  • Participates in Laboratory Investigations for Invalid assays and Out-of-Specifications results.
  • Prepares documents for storage in our document management system and manages original data files.

Skills:

  • Intermediate computer skills (i.e., Microsoft programs)
  • Working knowledge of industry/regulatory standards and GMP/GLP requirements
  • Preferred working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR
  • Intermediate computer skills (i.e., Microsoft programs)
  • Intermediate computer skills (i.e., Microsoft programs)
  • Working knowledge of industry/regulatory standards and GMP/GLP requirements
  • Working knowledge of industry/regulatory standards and GMP/GLP requirements
  • Preferred working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR
  • Preferred working knowledge of Enterprise Resource Planning (ERP), LIMS, and/or QSR

Education/Experience:

  • Bachelor’s degree in a science-related field
  • Bachelor’s degree in a science-related field
  • Bachelor’s degree in a science-related field
  • 1 to 2 years of industrial lab experience (preferably QC)
  • 1 to 2 years of industrial lab experience (preferably QC)
  • 1 to 2 years of industrial lab experience (preferably QC)

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