Senior QC Analyst

Catalent; Dartford; On-site; GBP 35,000 - 55,000; Full time

Job summary

An established industry player is seeking a Senior QC Analyst to join its Dartford team. This role involves performing critical analytical testing and ensuring compliance with cGMP standards. The successful candidate will have a strong background in laboratory practices, particularly in particle size analysis and HPLC. You'll have the opportunity to mentor junior staff and contribute to the continuous improvement of quality control processes. This forward-thinking company is dedicated to advancing healthcare solutions and offers a dynamic work environment where your expertise will make a significant impact.

Qualifications

• Proven laboratory experience in a cGXP environment.
• Ability to mentor and train junior staff in QC principles.

Responsibilities

• Perform analytical testing compliant with cGMP requirements.
• Prepare and review analytical test reports for client submissions.

Skills

HPLC

Particle Size Analysis

Method Development

Troubleshooting

Training and Mentoring

Education

Science Degree

Tools

Malvern Mastersizers

Sympatec

FTIR

Raman

DSC

Karl Fischer

Empower Software

Job description

Catalent Dartford, England, United Kingdom

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Catalent Dartford, England, United Kingdom

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At Catalent, our shared goal is to put patients first and help people worldwide live healthier lives. Catalent is a global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply. We seek dedicated individuals who share our passion for excellence and are driven to make a positive impact on millions of lives globally.

We are currently recruiting a Senior QC Analyst to join our Dartford team, which specializes in particle size reduction technologies and integrated analytical services for the pharmaceutical industry.

Shift-based role:

• Early shift: 6am - 2pm, Monday-Friday
• Late shift: 1:30pm - 10pm, Monday-Thursday; 1:30pm - 7pm, Friday
• Night shift: 9pm - 7am, Monday-Thursday

The Role:

• Perform analytical testing accurately, timely, and efficiently, compliant with cGMP requirements. Testing may include particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation, DSC, microscopy, moisture content (Karl Fisher), troubleshooting, technology transfer, and pharmacopoeia analyses.
• Implement and maintain 5S methodology in QC.
• Support QC metrics management.
• Train and mentor new QC team members, explaining basic principles of analysis.
• Stay updated on industry/regulatory developments related to particle size technology.
• Maintain understanding of PSA, HPLC, DSC equipment and methods.
• Prepare and review SOPs, including corporate and departmental guidelines.
• Prepare, review, and execute analytical test reports for client submissions and internal use, including Statements of Results, Certificates of Analysis, Validation Protocols, and Technical Transfer Studies.
• Ensure GMP compliance, including deviation management, change control, and investigations.
• Maintain data integrity of laboratory equipment and software systems.

The Candidate:

• Science graduate or higher with proven laboratory experience in a cGXP environment or extensive industry experience.
• Particle size analysis experience is desirable.
• Experience with HPLC: Empower software, troubleshooting, method development, and validation is essential.
• Experience in QC labs: investigations, CAPAs, deviations, SOP writing.
• Ability to mentor and train junior staff.

Catalent offers rewarding career opportunities! Join the global leader in drug development and delivery, helping bring over 7,000 products to patients worldwide. We are a growing international company working with pharma, biopharma, and consumer health companies to advance medicines from development to market. Join us in making a difference.