Werfen North America
Technologist I, QC - San Diego
Werfen North America, San Diego, California, United States, 92189
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Technologist I, QC - San Diego
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Werfen North America Position Summary
The QC Technologist I is responsible for the execution of a broad range of bench test procedures used in the testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory. The QC Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards. This is a temporary role lasting between 3 and 6 months, with the possibility of extension. The pay rate for this position is $19-$24/hr, depending on experience. Responsibilities
Perform testing finished goods per relevant SOP. Assist with testing as required for product validation and process validation on existing products. Maintain proper laboratory housekeeping and ensure adequacy of supply levels in the QC laboratory by informing appropriate personnel of low supply levels as required. Document all finished goods test results and maintain product release records (including electronic records). Document existing product/process validation test results (including electronic records). Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs. Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes. Other duties as assigned. Qualifications
High school diploma required; Bachelor’s degree in Science or equivalent experience preferred. Phlebotomist experience required. Understanding of Good Laboratory Practices (GLP) preferred. Previous experience in a Quality Control (QC) lab and/or Quality Assurance (QA) role within regulated medical device manufacturing or In-Vitro Diagnostic device (IVD) manufacturing Phlebotomy certification a plus. Knowledge of FDA-GMP/QSR and ISO standards for quality a plus. Good written and verbal communication skills. Ability to work as part of a team. Basic skills with common laboratory techniques, such as pipetting and use of balances. Basic skills with Microsoft Office suite. Basic skills with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems a plus. Seniority level
Entry level Employment type
Temporary Job function
Quality Assurance Industries
Medical Equipment Manufacturing
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Technologist I, QC - San Diego
role at
Werfen North America Position Summary
The QC Technologist I is responsible for the execution of a broad range of bench test procedures used in the testing of finished goods prior to release, assisting with investigations of product performance, routine validation studies, and housekeeping within the Quality Control (QC) laboratory. The QC Technologist I maintains the documentation of approved QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards. This is a temporary role lasting between 3 and 6 months, with the possibility of extension. The pay rate for this position is $19-$24/hr, depending on experience. Responsibilities
Perform testing finished goods per relevant SOP. Assist with testing as required for product validation and process validation on existing products. Maintain proper laboratory housekeeping and ensure adequacy of supply levels in the QC laboratory by informing appropriate personnel of low supply levels as required. Document all finished goods test results and maintain product release records (including electronic records). Document existing product/process validation test results (including electronic records). Maintain product testing database and perform relevant statistical analyses associated with product specifications as specified in laboratory SOPs. Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes. Other duties as assigned. Qualifications
High school diploma required; Bachelor’s degree in Science or equivalent experience preferred. Phlebotomist experience required. Understanding of Good Laboratory Practices (GLP) preferred. Previous experience in a Quality Control (QC) lab and/or Quality Assurance (QA) role within regulated medical device manufacturing or In-Vitro Diagnostic device (IVD) manufacturing Phlebotomy certification a plus. Knowledge of FDA-GMP/QSR and ISO standards for quality a plus. Good written and verbal communication skills. Ability to work as part of a team. Basic skills with common laboratory techniques, such as pipetting and use of balances. Basic skills with Microsoft Office suite. Basic skills with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems a plus. Seniority level
Entry level Employment type
Temporary Job function
Quality Assurance Industries
Medical Equipment Manufacturing
#J-18808-Ljbffr