Quality Control Technologist III

Overview

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and bio-materials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary

This job is a lead role in the quality control laboratory, performing routine activities and assisting the manager in daily operations. This person knows how to execute all test methods performed in the lab. They schedule all testing activities in the lab and report status in daily update meetings. The train new employees, perform OOS and root cause investigations, perform data/record review, lead projects, and updates WIN/SOPs.

Responsibilities

• Provides direction and guidance to Quality Control staff in the performance of daily tasks.
• Creates daily and weekly scheduling of all QC related activities.
• Schedules and performs testing for incoming raw material, in-process, final release and inspection of BioArray products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined timeframes.
• Schedules and performs stability, method validations, equipment validations, threshold analysis process and other special testing.
• Act 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’s).
• 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.
• Stay up-to-date on medical device regulations.
• Participate in internal and external audits.
• Perform other duties and responsibilities as assigned.

Qualifications

• Bachelor’s degree in biology or chemistry or 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 training QC technicians desired.
• Experience performing PCR (Polymerase chain reaction) desired.
• Experience in internal/external audits is a plus.

Reasonable Accommodations

Networking/Key relationships This role will ineract 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 Ineract With The Following External Partners External auditors Regulatory agencies

Skills & Capabilities

• Ability to accurately pipette solutions from 0.01 ul 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 protective equipment).
• Overtime work may be required (occasionally).
• Ability to lead others to complete tasks and projects.