Lead Chemist - Merz North America, Inc

About the Company: 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.

Key Responsibilities:

Quality Control testing SME:

• Serve as the SME for Laboratory test methods and equipment.

Laboratory Investigations:

• 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.

Scheduling:

• Coordinate scheduling of laboratory staff, resources and procedures to support manufacturing needs (raw materials, finished goods, validation, in-process and final product testing.

 Quality System Support:

• 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.

New technology:

• 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.

Audits:

• Participate with federal, state, and local regulatory officials during regulatory inspections. Perform internal and vendor quality system audits.

Education:

• BS/BA in Physical Science or related field with min 7 years’ experience in Quality Laboratory. Required.
• ASQ Certification as a Quality Auditor, Quality Technician, Quality Engineer, or equivalent.

Professional experience:

• GLP/GMP experience. Required.
• Pharmaceutical/Medical Device experience. Preferred.

Knowledge, skills, and abilities:

• 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. Required
• Quality experience may include quality testing (analytical chemistry/microbiology), QA/Regulatory, or Validation. Required.
• Experience with FDA, European agency regulations, cGMP regulations, Laboratory Information Management Systems (LIMS) and Quality Management software. Preferred.
• Good Microsoft 365 suite skills (Outlook, Excel, PowerPoint, Word). Required.
• Good organizational and time management skills that allow coordination and direction of day-to-day activities. Required.
• Ability to prepare testing protocols and reports, operating documents, and procedures. Required.
• Ability to work with little or no supervision and make effective decisions. Required.

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!

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

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Quality