Quality Control Technician - Hereford - ADM

    ADM
    ADM Hereford

    2 weeks ago

    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.

    Main Responsibilities

    • Sample Requests
    • Manufacture customer samples.
    • Review and update product specifications as necessary.

    Method Development

    • 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.

    Method Validation

    • Perform validation in accordance with ICH guidelines (accuracy, linearity, precision, repeatability, range, etc.).
    • Write validation protocols and reports.

    Product Transfer

    • Assess product formulation, manufacturing equipment, and processes.
    • Replicate products and processes using Hereford's equipment.
    • Adjust formulations as needed (e.g., additions, evaporation).
    • Implement process improvements (yield, standardization).
    • Create Work Manufacturing Procedures (WMP) for Hereford processes.
    • Monitor and assist in trial production runs.

    New Product Development

    • 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.

    Product Reformulation

    • Investigate reasons for reformulation (QC issues, production challenges, regulatory or customer requirements).
    • Modify processes or formulations as needed (e.g., extraction method, raw material changes).
    • Update specifications, WMP, MMF, yields, and request MSDS.
    • Manufacture customer samples.
    • Monitor and assist in trial production runs.

    Specifications

    • Review and update botanical and animal feed specifications.
    • Liaise with regulatory teams as required.

    Change Controls, Deviations, NCPNs

    • Write or advise on change controls, deviations, and NCPNs when required.

    Botanical Department Support

    • Provide advice and resolve product or process issues.
    • Manage product re-works and update yields/WMPs.

    Quality Control

    • Troubleshoot analytical problems and advise on QC/BP methods.
    • Review botanical additions and calculate irregular additions.
    • Maintain and repair analytical instruments.
    • rain 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.

    Customer Support

    • Address customer complaints through analysis and root cause determination.
    • Respond to customer queries promptly.

    Raw Material Evaluation

    • Assess new raw materials for suitability (analysis, specification, supplier compliance, monograph requirements).

    Skills & Abilities

    • Strong analytical and problem-solving skills.
    • Excellent communication and documentation abilities.

    Education & Experience

    • Degree in Chemistry, Pharmaceutical Sciences, or related field.
    • Experience in method development, validation, and product formulation.
    • Knowledge of ICH guidelines and regulatory requirements.

    Seniority level: Associate

    Employment type: Full-time

    Job function: Quality Assurance

    Industries: Food and Beverage Manufacturing

    Location: Hereford, England, United Kingdom


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