Required Skills & Experience
Responsibilities
Lead raw material qualification and equivalency studies for new, alternate, changed, or at-risk raw materials. Develop validation strategies, experimental plans, acceptance criteria, sampling approaches, and testing sequences. Conduct and oversee microbiological and experimental testing to understand the impact of raw material variability. Manage multiple qualification projects, timelines, laboratory resources, documentation, and stakeholder communication. Analyze technical data and use statistical methods to identify trends, atypical results, and testing gaps. Prepare validation protocols, technical reports, summaries, and recommendations. Partner with Quality, Operations, Procurement, Product Development, Manufacturing Engineering, and suppliers. Lead troubleshooting and root cause analysis related to unexpected qualification results or raw material performance. Ensure work complies with applicable procedures, cGMP, ISO, data-integrity, safety, and environmental requirements. Support change management, supplier changes, process improvements, and supply-continuity initiatives. Must-Haves Bachelor's degree in Biochemistry, Chemistry, Biological Science, Microbiology, Engineering, or related field. 5+ years of relevant experience within research, product engineering, quality, manufacturing, validation, or a related technical environment. Experience with experimental design, validation, technical documentation, and scientific data interpretation. Ability to independently manage multiple technical projects and drive them through completion. Strong problem-solving and root cause analysis skills. Strong written and verbal communication skills
Nice to Have Skills & Experience
Preferred Qualifications Experience with traditional microbiology and/or dehydrated culture media. Experience with raw material qualification and supplier or material changes. Experience with microbiological or analytical testing and validation studies. Experience working within a regulated manufacturing environment. Knowledge of cGMP, ISO requirements, statistical analysis, change control, and data-integrity practices. Experience evaluating how raw material variability impacts microbiological or finished-product performance
Job Description
Job Description
Insight Global is seeking a Raw Material Qualification Consultant to support a client in Lansing, MI. This individual will be responsible for leading raw material qualification and validation activities supporting dehydrated culture media and other commercialized microbiology products. The consultant will independently manage qualification projects from experimental design and testing through data analysis, risk assessment, documentation, and final recommendations. This role will work cross-functionally with Quality, Operations, Procurement, Product Development, Manufacturing Engineering, and suppliers.