QC Technologist III

Overview

The QC Lab 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 Lab 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 Lab Technologist III supports investigations and performs in depth analysis of the trending of finished product testing data. The QC Lab Technologist III manages basic projects independently of management.

The base hourly range for this role is currently $34.00/hr. to $39.00/hr individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

Key Accountabilities

Essential Functions:

• Perform testing of finished goods per relevant SOP.
• Perform testing for product validation and process validation on new and existing products and demonstrate the ability to understand the validation. Assist with the development of validation, including feedback on testing requirements and turn around time.
• Maintain proper laboratory housekeeping and supply levels in the QC laboratory, including submission of purchase requisitions and inventory adjustments and exhibiting knowledge of product usage based on planned production to ensure safety stock and continued supply.
• Document all test results and maintain product release records (including electronic records).
• Maintain product testing database and trending associated with product specifications as specified in laboratory SOPs.
• As required, coordinate and assist with investigations and resolution of complaints, non‑conforming material and product performance issues, including recommending and organizing test protocols for investigation.
• Perform testing of biological raw materials, including range generation or characterization. Organize and complete associated paperwork. As required, manage concentration selection and release. Organize and schedule basic testing requirements with minimal supervision.
• Perform testing and prepare reports as required, such as environmental monitoring reports or investigation of out‑of‑specification results, as required.
• Responsible for tracking and analyzing trends related to release testing. Ability to use analysis of trends to provide input on product issues and results.
• Perform testing and assist with preparation of reports for various special projects as deemed necessary by technical review team.
• Responsible as a subject matter expertise in at least one product line.
• Submit complex change orders to update procedures as required.
• As required, interact independently with cross‑functional teams to obtain information on testing, provide feedback and information, and demonstrate critical evaluation of testing requests. Assist the cross‑functional team to investigate and resolve issues.
• Exhibit ability to manage multiple projects/responsibilities with little supervision.
• Ensure and maintain compliance with the Company’s quality system requirements through training and adherence to policies, procedures and processes.
• Other duties as assigned.

Internal Networking/Key Relationships:

• Quality Release, Research and Development, Quality Engineering, and Manufacturing Personnel.

Minimum Knowledge & Experience Required for the Position:

• High school diploma required, Bachelor’s degree in Science or equivalent experience preferred.
• Work Experience:
  • Without Related degree: A minimum of five (5) years previous Quality Control lab (QC) and/or Quality Assurance (QA) experience required
  • With Related degree: 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…