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. 

Licensed Phlebotomist is a requirement for this position. Phlebotomist will be responsible for scheduling internal volunteers for donations and drawing up to 20 donors a day. Employee will perform the other functions of the Tech 1 on a rotating basis.

The pay range for this role is $19-$24/hr depending on experience.

Key Accountabilities

Essential Functions:

• 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.

Minimum Knowledge & Experience Required for the Position:

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