QC Analyst - Biopharma Lab, Flexible Hours, HPLC

Sanofi Inc.; Worcester; On-site; GBP 34,000 - 47,000; Full time

Job summary

Sanofi Waterford is seeking a QC Analyst on a fixed-term, full-time basis to provide analytical chemistry services in support of diverse manufacturing operations. You will engage with the Continuous Improvement programme, maintain methods and SOPs, and ensure compliance with cGLP and pharmacopoeial requirements.

The role involves collaboration with QA, Production, Engineering and Planners, plus training analysts and contributing to OOS investigations and new product introduction projects.

Qualifications

• Degree in Science (Chemistry or Biochemistry preferred).
• Post-graduate studies to augment primary degree.
• Operational experience in quality laboratories within a fast-moving manufacturing environment.
• Detailed knowledge of quality systems, pharmaceutical manufacturing, cGLP, pharmacopoeial methods and stability.
• Understand relevant quality/compliance regulations.
• Able to manage projects to plan and budget.
• Minimum two years HPLC/Empower experience.

Responsibilities

• Provide analytical chemistry services and support to Site.
• Interact with other departments on raw materials, intermediates and finished batch releases.
• Maintain, update and issue chemical methods, specifications and SOPs in compliance to pharmacopoeial and regulatory requirements.
• Assist with training of analysts in areas of expertise and new methods, SOPs and updates.
• Trend results, record on COAs where required and complete OOS investigations timely.
• Update QC Team Leader on potential problems and improvements via standard communication channels.
• Ensure that critical testing and related equipment meet validation requirements (IQ/OQ/PQ) where required.
• Audit and review chemistry test results daily and ensure compliance with cGLP.
• Ensure all quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

Quality labs

Regulatory knowledge

Project management

Education

Science degree (Chemistry/BioChem)

Postgraduate studies

Tools

HPLC/Empower

Job description

Sanofi Waterford is seeking a QC Analyst on a fixed-term, full-time basis to provide analytical chemistry services in support of diverse manufacturing operations. You will engage with the Continuous Improvement programme, maintain methods and SOPs, and ensure compliance with cGLP and pharmacopoeial requirements.

The role involves collaboration with QA, Production, Engineering and Planners, plus training analysts and contributing to OOS investigations and new product introduction projects.