Innovations Technologist; Botanicals
Listed on 2025-12-30
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Quality Assurance - QA/QC
Quality Control / Manager, Quality Engineering
Job Description
This role involves leading and supporting activities across product development, method development, validation, transfer, and quality control. The position requires strong technical expertise, problem‑solving skills, and collaboration with cross‑functional teams to ensure compliance with regulatory standards and deliver high‑quality products.
Responsibilities- Sample requests and manufacture customer samples.
- Review and update product specifications as necessary.
- Select appropriate technology and define method parameters (e.g., temperature, flow rate, wavelength, column, mobile phase, injection volume, oven temperature).
- Prepare samples and standards; establish system suitability requirements.
- Develop QC methods; write protocols and reports.
- Provide training on new methods.
- Perform validation in accordance with ICH guidelines (accuracy, linearity, precision, repeatability, range, etc.).
- Write validation protocols and reports.
- Assess product formulation, manufacturing equipment, and processes.
- Replicate products and processes using Hereford’s equipment.
- Adjust formulations as needed (additions, evaporation).
- Implement process improvements (yield, standardization).
- Create Work Manufacturing Procedures (WMP) for Hereford processes.
- Monitor and assist in trial production runs.
- Formulate materials per monograph requirements.
- Establish yield and manufacturing processes via laboratory trials.
- Create addition and assay spreadsheets; prepare provisional specifications, WMP, and final specifications.
- Request MSDS and complete MMF documentation.
- Develop new QC test methods if required.
- Monitor and assist in trial production runs and scale‑up.
- Investigate reasons for reformulation (QC issues, production challenges, regulatory or customer requirements).
- Modify processes or formulations as needed (extraction method, raw material changes).
- Conduct laboratory‑scale trials.
- Update specifications, WMP, MMF, yields, and request MSDS.
- Manufacture customer samples.
- Monitor and assist in trial production runs.
- Review and update botanical and animal feed specifications.
- Liaise with regulatory teams as required.
- Write or advise on change controls, deviations, and NCPNs when required.
- Provide advice and resolve product or process issues.
- Manage product re‑works and update yields/WMPs.
- Troubleshoot analytical problems and advise on QC/BP methods.
- Review botanical additions and calculate irregular additions.
- Maintain and repair analytical instruments.
- Train analysts on new methods, irregular tests, and equipment.
- Conduct taste panels and manage retest extensions.
- Review protocols and reports.
- Perform botanical testing and manage sample records.
- Track ethanol usage.
- Address customer complaints through analysis and root cause determination.
- Respond to customer queries promptly.
- Assess new raw materials for suitability (analysis, specification, supplier compliance, monograph requirements).
- Strong analytical and problem‑solving skills.
- Excellent communication and documentation abilities.
- Degree in Chemistry, Pharmaceutical Sciences, or related field.
- Experience in method development, validation, and product formulation.
- Knowledge of ICH guidelines and regulatory requirements.
Diversity, equity, inclusion and belonging are cornerstones of ADM’s efforts to continue innovating, driving growth, and delivering outstanding performance. We are committed to attracting and retaining a diverse workforce and create welcoming, truly inclusive work environments – environments that enable every ADM colleague to feel comfortable on the job, make meaningful contributions to our success, and grow their career. We respect and value the unique backgrounds and experiences that each person can bring to ADM because we know that diversity of perspectives makes us better, together.
For more information regarding our efforts to advance Diversity, Equity, Inclusion & Belonging,…
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