Technologist III, QC - San Diego

Overview

Position Summary:

The QC Technologist III is responsible for the execution of a broad range of bench test procedures used in raw material qualification, the testing of finished goods prior to release, the investigations of product performance, and for conducting routine validation studies, as well as assisting with routine maintenance of the Quality Control (QC) laboratory. The QC Technologist III works with cross-functional teams to resolve product performance issues and maintenance of QC Standard Operating Procedures (SOP) in compliance with applicable regulations and ISO standards. Additionally, QC Technologist III supports investigations and assists in trending and statistically analyzing finish product testing data.

Responsibilities

Key Accountabilities

Essential Functions:

• Perform and organize testing of biological raw materials and finished goods per relevant SOP with minimal supervision; subject matter expertise in at least one product line.
• Assist with planning of method, product and process validations on existing products; perform and organize testing as needed.
• Perform testing and prepare reports as required for environmental monitoring or investigation of out-of-specification results, as required.
• Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team.
• Responsible for tracking relevant trends.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments.
• Document all 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.
• As required, coordinate and assist with investigation and resolution of complaints, non-conforming material and product performance issues.
• Submit complex change orders to update procedures as required.
• As required, work cross-functionally to investigate and resolve issues deriving from finish product testing.
• 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

Minimum Knowledge & Experience Required for the Position:

• High school diploma required; Bachelor’s degree in Science or equivalent experience preferred.
• A minimum of four (4) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required; previous experience within a regulated medical device manufacturing or In-Vitro Diagnostic Device (IVDD) strongly preferred.
• Thorough understanding of Good Laboratory Practices (GLP) required.
• Practical experience with laboratory controls, internal audits, and lab training/maintenance.
• Phlebotomy certification a plus.
• Knowledge of FDA-GMP/QSR and ISO standards for quality.
• Excellent written and verbal communication skills.
• Ability to work independently and as part of a team.
• Proficiency with common laboratory techniques, such as pipetting and use of balances.
• Proficiency with Microsoft Office suite.
• Proficiency with Large Enterprise Resources Planning (ERP) and Laboratory Information Management (LIMS) systems preferred.