Spclst, Quality Control

Job Description

Responsibilities

• Completes a variety of analytical testing to support stability requirements for a variety of products

• Supports all areas of the QC laboratory, cross-training and providing testing support in various work cells

• Provides training to other teammates and serves as subject matter experts

• Works with our company's sites to ensure delivery schedules of samples to be tested are met

• Maintains compliance by following corporate policies/guidelines and local procedures

• Supports and leads continuous improvement projects with minimal assistance and works to ensure the sustainability of implemented changes identified through lean six sigma tools/activities

• Identifies and implements changes focused on improving compliance performance in the laboratory

• Leads Tier I Activities and coordinates daily activities to ensure on-time, compliant testing is completed within their work cell

• Actively participates in Tier II as needed

• Demonstrates an in-depth understanding of product performance and testing methodology and able to train others on both

• Identifies proactive measures to ensure right first time achievement

• Leads remediation of walk-thru audits observations and works to ensure compliant operation of the laboratory to ensure successful outcomes of audits

• Works cross-functionally to ensure proper prioritization/effective utilization of laboratory equipment

• Tests and interprets results for components, active pharmaceutical ingredients, finished pharmaceutical products, and stability samples

• Interprets compendial and internal monographs, NDAs, CFR and our company's Quality Standards 

• Ensures laboratory compliance by adhering to cGMP, CFR, EU, and other agency regulations

• Identifies improvement opportunities and both independently and as a facilitator of change, implements improvements

• Learns a variety of tools to drive continuous improvement (lean six sigma, human error prevention, etc.)

• Maintains a safe workplace and identifies actions to prevent safety incidents in the laboratory

• Maintains 5S organization throughout the laboratory and leads 5S activities to ensure compliance

• Provides guidance and coaching to new analysts within and outside his/her cell

Education Requirements

• Bachelor degree in Chemistry

Required Experience and Skills

• Minimum three (3) years of relevant work

• Knowledge of continuous improvement principles

• Operating routine laboratory equipment including but not limited to: HPLC, Karl Fisher, Drug Dissolution, pH meter, etc.

• Knowledge of regulatory and cGMP requirements

• Utilizing Empower or any other data acquisition software

Preferred Experience and Skills

• Managing Active Pharmaceutical Ingredients material testin