Quality Control Associate I

A Brief Overview

This role is responsible for executing daily activities in the QC Laboratory including support testing on the production of Merz Aesthetic product. Oversee and/or assist with tasks related to the activities associated with operation of Merz Quality System and as directed by Quality Management. Support all activities related to analytical assessment of Merz NA products and the manufacturing environment. Advise Quality Assurance, Manufacturing and MS&T departments on matters related to analytical testing and support. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System.

What You Will Do

• Execute product testing in accordance with established test methods and procedures.
• Support laboratory investigations and implement corrective and preventive actions, reduce finished product average cycle time, and reduce laboratory related errors through method improvements and effective training.
• Evaluate and implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures.
• Initiate and/or support the development of protocols and final reports for sterilization, evaluation of new materials or other quality control projects.
• Demonstrate proficiency in assigned analytical test methods.
• Support manufacturing needs by ensuring testing and inspection for raw materials, finished goods, validation, in-process material and final products is completed accurately, timely and documented correctly.
• Support other Quality System functions related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventative Actions, product complaint investigations, audits, and other tasks as directed.
• Participate in/support new-hire training and orientation, and on-going training and development of Quality Control Team.
• Support investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework.
• Recommend operational changes to improve efficiencies.
• Participate with federal, state, and local regulatory officials during regulatory inspections and support internal and vendor quality system audits.

Minimum Requirements

Bachelor's Degree BS/BA in Physical Science or related field.

Preferred Qualifications

• Experience in Quality Laboratory
• GLP/GMP experience
• Pharmaceutical and/or other regulated industry or similar experience

Technical & Functional Skills

• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, or Validation.
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Management Systems (LIMS) and Quality Management software is highly preferred.
• Knowledge of quality systems, quality techniques, current regulatory requirements and technical issues resolution.
• Preferred proficiency with equipment in the lab, as well as equipment preventative maintenance and method/process troubleshooting.
• Familiarity with general laboratory and incoming supply inspection testing.
• Computer skills including word processing, spread sheet programs, databases and statistical analysis.
• Ability to work with little or no supervision and make effective decisions.