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Quality Assurance Specialist
2 months ago
Job Title: Quality and Control Analyst
Location: Derbyshire
Salary: Starting at 28K
Job Summary:
We are seeking a highly skilled Quality and Control Analyst to join our team at Kenton Black Ltd. As a Quality and Control Analyst, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities:
- Conducting analytical testing of raw materials, intermediates, and finished products in accordance with the testing plan.
- Communicating any inability to meet the testing plan and ensuring appropriate reporting.
- Contributing to the trending of results, investigating and reporting any Out of Specification (OOS) and Out of Trend (OOT) results.
- Generating reports, including stability reports, within agreed timelines.
- Assisting in the calibration, validation, and monitoring of laboratory equipment.
- Collaborating with other laboratory members to solve problems related to methods and testing.
- Participating in the transfer of test methods to/from the analytical laboratory to customers or third parties.
- Cultivating a culture of continuous improvement through root cause analysis and risk management tools.
- Adhering to Health and Safety, Good Manufacturing Practice, and relevant guidelines and legal obligations.
Requirements:
- 2-3 years experience working with HPLC in a GMP regulated environment.
- Bachelor's degree in a related scientific field (e.g., Chemistry, Biochemistry).
- Familiarity with industry regulations and standards.
- Strong teamwork and communication aptitude.
- Strong analytical and problem-solving skills.
- Basic knowledge in root cause analysis and risk management.
- Timely management of workload to meet targets.
Skills and Qualifications:
- Lab analyst
- Compliant operations
- Analytical testing
- Raw materials
- Intermediates
- Finished products
- Out of Specification (OOS)
- Out of Trend (OOT)
- Result trending
- Stability reports
- Investigations
- Equipment calibration
- Equipment validation
- Method development
- Method validation
- Root cause analysis
- Risk management tools
- Data analysis
- Good Manufacturing Practice (GMP)
- Deviations
- Quality control
- Problem-solving
- Continual improvement
- Process enhancement
- Compliance
- Culture of improvement