Quality Control Technologist III

Overview

Job Summary

This job is a lead role in the quality control laboratory, performing routine activities and assisting the manager in daily operations. The successful candidate executes all test methods performed in the lab, schedules testing activities, reports status in daily update meetings, trains new employees, performs OOS and root cause investigations, reviews data and records, leads projects, and updates WIN/SOPs.

• Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities.
• Performs and schedules testing for incoming raw material, in‑process, final release and inspection of Bio Array products according to approved SOPs and other applicable documents within defined time frames. Performs and schedules stability, method validations, equipment validations, threshold analysis processes and other special testing.
• Acts as OJT trainer to train new employees and current employees on new test methods. Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions.
• Reports and escalates out‑of‑specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out‑of‑specification results and deviations.
• Writes/revises SOPs, WI, QC specification/testing documents. Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP).
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Performs, schedules and delegates equipment calibration and maintenance.
• Performs data review of QC test data. Works with quality assurance (QA) to ensure batch records are approved in a timely manner.
• Stays up‑to‑date on medical device regulations. Participates in internal and external audits.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

This role interacts with the following areas within the company (at a minimum):

• Quality Assurance and Quality Control
• Operations
• Regulatory Affairs
• Technical Support and R&D

This role may interact with the following external partners:

• External auditors
• Regulatory agencies

Minimum Knowledge & Experience required for the position:

• Bachelor’s degree in biology or chemistry or a related field. Five (5) or more years experience in a medical device or pharmaceutical GMP quality control laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired.
• Two (2) or more years of experience performing out of specification (OOS) and/or root cause investigations (RCI) required. Experience with test method validation, performing data trending, and writing/revising SOP/WIN preferred.
• Experience performing OOS Phase I investigations, in alignment with FDA guidelines, required.
• Experience in internal/external audits is a plus.

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Skills & Capabilities:

• Ability to accurately pipette solutions from 0.01 µl up to 10 ml.
• Critical thinking and problem‑solving abilities.
• Ability to learn and work with software programs (off‑the‑shelf and company‑designed).
• Ability to work in a GMP lab environment, including donning the appropriate PPE (personnel…