Quality Control Technician

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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