Overview In this role you ensure high-quality products by leading analytical lab activities, validating and maintaining methods, and maintaining data integrity. You'll support ISO 9001, EFfCI, EXCiPACT and other standards while collaborating with site and corporate teams. You drive instrument upkeep, method transfers, and continuous improvement in a fast-paced manufacturing environment. This is a visible, impact-focused position that strengthens the site's Quality function.
Compensation / Benefits- competitive salary and benefits
- pay-for-performance incentive plans
- diverse work environment
- opportunities for development and advancement
- Equal Opportunity Employer
- comprehensive safety programs
Responsibilities- Oversee laboratory instrument operations affecting product quality
- Maintain documented test methods and work instructions
- Validate analytical laboratory methods and ensure compliance
- Manage preventive maintenance and calibration checks for lab equipment
- Troubleshoot instrument and analytical issues
- Monitor data drift and trends in laboratory data
- Perform non-routine testing for instrument validation or method transfers
- Develop method equivalency and Gage R&R studies
- Coordinate documentation to support certifications and data integrity
- Provide training on analytical testing, safety, cGMP and ISO-9001 standards
- Support quality, safety and environmental initiatives
Key requirements- Bachelor of Science in Chemistry or closely related discipline
- Minimum of 5 years of laboratory experience
- Expertise in gas chromatography
- Knowledge of cGMP, ISO 9001 and quality assurance systems
- Experience with data integrity and statistical quality control
- Working knowledge of SAP and Microsoft Office Suite
- Strong communication skills with cross-functional interface
- Effective communication
- Cross-functional collaboration
- Problem-solving mindset
- Gas chromatography
- Analytical method development
- Gage R&R
