Raw Materials Qualification Consultant

Insight Global; Lansing (MI); On-site; USD 90,000 - 120,000; Full time

Job summary

Insight Global in Lansing, MI is seeking a Raw Material Qualification Consultant to lead qualification and validation of dehydrated culture media and other microbiology products.

You will manage qualification projects from experimental design to data analysis, work cross-functionally with Quality, Operations, Procurement, Product Development and suppliers, and develop validation strategies while ensuring cGMP and data integrity.

Qualifications

• 5+ years of relevant experience in 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.

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.

Skills

Project management

Analytical thinking

Strong communication

Statistical analysis

Education

Bachelor's in Biochemistry or related

Tools

Quality systems

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.

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, 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

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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail]. To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.