Senior QC Analyst

At Catalent we share a common goal: to put patients first and help people around the world live better and healthier lives. Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. We need great people who share our passion for excellence and have the drive and determination to make a difference, positively impact the lives of millions of people across the globe.
Catalent is currently recruiting for a Senior QC Analyst to join the Dartford team. This facility 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 in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis (Malvern Mastersizers, Sympatec), cleaning verification (HPLC), identification testing (FTIR and Raman), method development and validation (including particle size and cleanability assessments), DSC, Light microscopy, SEM, Moisture content (Karl Fisher), method optimisation and troubleshooting, technology transfer and pharmacopoeia analyses as appropriate.
• Drive implementation and maintenance of the 5S methodology in QC.
• Support the management of QC metrics.
• Act as a trainer to new members of the QC team, including providing explanation on the basic principles of operation with regards to analysis being performed.
• Keep up to date with industry/regulatory developments in relation to particle size technology.
• To have a good understanding of PSA / HPLC/ DSC analytical equipment and methods.
• Prepare and review Standard Operating Procedures (SOP’s), including corporate and departmental guidelines.
• Prepare, review and execute analytical test reports for submissions to clients or other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates, Method Qualification/ Validation Protocols, Method Qualification/Validation Reports and Laboratory Technical Transfer Studies.
• Experience of GMP requirement with regard to laboratory activities including deviation, change control and laboratory investigation.
• Ensure compliance with data integrity requirements of laboratory equipment and software systems.
  

The candidate:

• Science graduate or higher with proven experience of laboratory operation in a cGXP environment or extensive industry experience.
• Particle Size experience desirable
• Experience in HPLC: Empower, Trouble shooting of equipment, Method Development and Validation essential.
• Experience in QC Lab: Investigations, CAPA’s, Deviations, Writing SOP’s
• Ability to mentor and train junior staff
  

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.