Catalent Dartford, England, United Kingdom
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Catalent Dartford, England, United Kingdom
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Join to apply for the Senior QC Analyst role at Catalent
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.
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