QC Analyst – Fixed-Term (Biopharma Chemistry)

Sanofi Inc.; Chelmsford; On-site; GBP 34,000 - 48,000; Full time

Job summary

Sanofi Waterford seeks a QC Analyst for a fixed-term, full-time role within the fast-paced manufacturing environment. You will deliver analytical chemistry services and collaborate across departments to ensure timely batch releases and ongoing quality improvements.

The position requires a chemistry/biochemistry background, HPLC/Empower experience, and a focus on regulatory compliance. Training of analysts and continuous improvement are key aspects of the role.

Qualifications

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

Responsibilities

• Provide analytical chemistry services and support to Site.
• Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
• In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
• Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory requirements.
• Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
• Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
• Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
• Ensure that critical chemical testing and related equipmentmeets current validation requirements (IQ, OQ, PQ) whererequired.
• Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
• Ensure all quality documentation and records are complete and current.
• Support new product introduction projects.

Skills

Quality control experience

HPLC/Empower experience

Project management

Education

Science degree in Chemistry or Biochemistry

Tools

HPLC/Empower

Job description

Sanofi Waterford seeks a QC Analyst for a fixed-term, full-time role within the fast-paced manufacturing environment. You will deliver analytical chemistry services and collaborate across departments to ensure timely batch releases and ongoing quality improvements.

The position requires a chemistry/biochemistry background, HPLC/Empower experience, and a focus on regulatory compliance. Training of analysts and continuous improvement are key aspects of the role.