Quality Control Associate I

Merz North America, Inc; Racine (WI); Presencial; USD 70 000 - 100 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical, Dental, and Vision plans

20 days Paid Time Off

15 paid holidays

Paid Sick Leave

Paid Parental Leave

401(k)

Employee bonuses

Resumo da oferta

Merz North America, Inc. in Racine, Wisconsin is seeking a Quality Control Laboratory Specialist to execute product testing and support the operation of the Quality System.

The role ensures analytical testing aligns with cGMP standards and QA guidance. You will collaborate with QA, Manufacturing and MS&T to test raw materials, in-process and finished products, and contribute to investigations, CAPA and documentation.

Qualificações

• Bachelor's Degree BS/BA in Physical Science or related field.
• Experience in Quality Laboratory.
• GLP/GMP experience.
• Pharmaceutical and/or other regulated industry experience.

Responsabilidades

• Execute product testing per established methods and procedures.
• Support laboratory investigations and CAPA initiatives to reduce errors and improve methods.
• Assist with documentation review, equipment calibration, nonconformance review, and audits.
• Support investigations related to product deviations and corrective actions.
• Participate in training and development of Quality Control staff.

Conhecimentos

Quality testing

Analytical chemistry

Laboratory experience

Regulatory knowledge

cGMP knowledge

Formação académica

Bachelor's degree in Physical Science or related field

Ferramentas

LIMS

Quality Management Software

Descrição da oferta de emprego

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

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

• Quality Testing: 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 around which the Quality System is developed. 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 : 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.
• Quality System Support: Support other Quality System functions as assigned by Quality Management that are related to documentation review, equipment calibration, nonconformance review, Out of Specification (OOS), Corrective and Preventative Actions, product complaint investigations (if applicable), audits, and other tasks as directed. Participate in/support new-hire training and orientation, and on-going training and development of Quality Control Team.
• Quality Testing: Evaluate and implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
• Support NCR and CAPA activities: Support investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, etc.
• Process Improvement Initiatives: Recommend operational changes to improve efficiencies
• Audit Support: Participate with federal, state, and local regulatory officials during regulatory inspections. 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 equipment and method/process troubleshooting.
• Familiarity with general laboratory and incoming supply inspection testing.
• Computer skills including those associated with word processing, spread sheet programs, databases and statistical analysis.
• Ability to work with little or no supervision and make effective decisions.

Benefits

• Comprehensive Medical, Dental, and Vision plans
• 20 days of Paid Time Off
• 15 paid holidays
• Paid Sick Leave
• Paid Parental Leave
• 401(k)
• Employee bonuses
• And more!

Your benefits and PTO start the date you're hired with no waiting period!

This position is not eligible for employer-sponsored work authorization. Applicants must be legally authorized to work in the United States without the need for current or future employer-sponsored work authorization.

Come join a company that is committed to being a trusted partner focused on our customers while not forgetting about our employees!