Technologist I – Qc

Technologist I – Qc

Requirements

• High school diploma required; Bachelor’s degree in Science or equivalent experience preferred.
• Phlebotomy certification 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.
• 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.

Responsibilities

• Operate as a phlebotomist.
• 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.

Preferred Qualifications

• Bachelor’s degree in Science or equivalent experience preferred.
• Understanding of Good Laboratory Practices (GLP) preferred.
• Knowledge of FDA-GMP/QSR and ISO standards for quality a plus.
• Basic skills with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems a plus.