Lead Chemist

Merz North America • Racine, WI

85d

About The Position

Merz is a family-owned medical device and pharmaceutical company headquartered in Germany. Our Global Technical Operations based in WI manufactures, packages and ships several innovative products so that people all over the world can live better, feel better, and look better. This position is responsible for providing engineering and technical support to the Quality Department, encompassing operations, sustaining engineering, R D, and New Product Introduction. The role supports a broad range of activities including Change Control, NCR/CAPA, Product Surveillance, Quality operations, Design Control, New Product Development, New Markets, Risk Management, and Post Market Surveillance. The role involves evaluating the operations of Manufacturing and Quality activities in relation to compliance with Quality Standards and Regulations and recommending corrections or improvements where necessary. It also includes providing direct support to Quality personnel in the operation of the department and the Quality System.

Requirements

• BS/BA in Physical Science or related field with min 7 years' experience in Quality Laboratory.
• ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent.
• GLP/GMP experience.
• Familiarity with cGMP regulations and FDA/USP/EP/BP/ICH guidelines.
• Proficiency with equipment in the lab, as well as equipment preventative maintenance equipment and method/process troubleshooting.
• 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.
• Good Microsoft 365 suite skills (Outlook, Excel, PowerPoint, Word).
• Good organizational and time management skills that allow coordination and direction of day-to-day activities.
• Ability to prepare testing protocols and reports, operating documents, and procedures.
• Ability to work with little or no supervision and make effective decisions.

Nice To Haves

• Pharmaceutical/Medical Device experience.

Responsibilities

• Serve as the SME for Laboratory test methods and equipment.
• Conduct 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.
• Coordinate scheduling of laboratory staff, resources and procedures to support manufacturing needs (raw materials, finished goods, validation, in-process and final product testing).
• Support other Quality System functions as assigned by the QC Laboratory Manager 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.
• Evaluate and implement new analytical technologies per Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.
• Implement new test methods as appropriate.
• Participate with federal, state, and local regulatory officials during regulatory inspections.
• Perform internal and vendor quality system audits.

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!

What This Job Offers

• Industry: Wholesale Trade Agents and Brokers
• Education Level: Bachelor's degree