Associate Chemist

Location: Fremont

Job Title:

Associate Chemist

Job Description

The Associate Chemist supports a laboratory within a food manufacturing facility by implementing and maintaining laboratory compliance systems, performing analytical testing, and ensuring that all laboratory activities meet internal standards and external regulatory requirements. This role develops, validates, and implements new analytical methods, interprets data trends to support corrective and preventive actions (CAPA), and contributes to overall product quality and safety.

The position is full-time and follows a 12-hour alternative night shift schedule from 6:00 PM to 6:00 AM in Fremont, MI.

Responsibilities

+ Understand and implement all relevant laboratory compliance systems, procedures, and guidelines.

+ Perform and maintain rapid versus reference method monitoring to ensure consistency and accuracy of test results.

+ Implement method validations and verifications, including planning, execution, and documentation of validation activities.

+ Create or revise work instructions and data logbooks to ensure clear, current, and compliant documentation practices.

+ Monitor conformance to internal control plans and promptly address deviations or nonconformances.

+ Order and maintain laboratory supplies to ensure continuous and efficient laboratory operations.

+ Research, develop, and implement new analytical methods and instruments to improve testing capabilities and efficiency.

+ Ensure compliance with all laboratory local instructions (LIs) and general instructions (GIs).

+ Understand and apply all quality assurance and NQAC requirements to ensure compliance with internal standards.

+ Provide support for compliance and contaminant testing programs, including keeping quality and stability programs.

+ Perform routine tests and laboratory analyses using established analytical methods and wet chemistry techniques.

+ Interpret and implement analytical methods according to internal and external requirements.

+ Demonstrate competency by successfully participating in proficiency test programs.

+ Use critical thinking to troubleshoot testing, sampling, and instrument abnormalities to ensure accurate reporting of results.

+ Maintain laboratory instruments, including routine maintenance, troubleshooting, and minor repairs.

+ Prepare samples for external testing and ensure proper labeling, documentation, and chain-of-custody procedures.

+ Perform peer review of laboratory data to verify accuracy, completeness, and compliance with procedures.

+ Evaluate method validation and verification data and write clear, concise final reports.

+ Create and maintain control charts using Excel or QStat programs to monitor analytical performance and trends.

+ Review laboratory data and conduct investigations of out-of-specification or out-of-trend results, documenting findings and supporting CAPA activities.

+ Collect data independently or as part of a team and present data summaries using Excel and appropriate charting tools.

+ Review and manage result reports from external laboratory testing and ensure proper integration into internal records.

+ Perform additional duties as assigned by management or team leaders to support laboratory and quality objectives.

Essential Skills

+ Hands-on laboratory experience in chemistry, including routine testing and wet chemistry techniques.

+ Strong understanding of laboratory quality control principles and practices.

+ Working knowledge of Good Manufacturing Practices (GMP) in a laboratory or manufacturing environment.

+ Ability to interpret and apply established analytical methods and procedures.

+ Competence in troubleshooting test methods, sampling issues, and instrument abnormalities.

+ Experience maintaining laboratory instruments, including routine maintenance and minor repairs.

+ Proficiency with Microsoft Excel for data entry, analysis, and creation of charts and control charts.

+ Ability to review, interpret, and validate laboratory data with a high level of accuracy and attention to detail.

+ Strong written skills for creating and revising work instructions, data logbooks, and validation reports.

+ Ability to work effectively on a 12-hour night shift schedule…