Quality Control Scientist Bioanalytical

Location: Harwell, OX11 0GD

Position Summary

The Bioanalytical QC Scientist main role is to perform all administrative and laboratory activities in order to evaluate the quality of the biological products with a GMP quality grade and in an efficient way. He/she masters all laboratory activities related to QC Bioanalytical and is able to anticipate and respond to any problems encountered during these laboratory activities. He/she supports other Bioanalytical QC Scientists in their practical training and in their daily laboratory activities.

The Bioanalytical activities cover the following topics within a GMP quality grade and in an efficient way: analytical tech transfers from analytical development or directly from customers, analytical verification and validations, Bioanalytical product testing, flow cytometry, HPLC, qPCR and other analytical testing.

The Role (daily responsibilities)

Conduct their work in strict compliance with data integrity; following ALCOA principles at all times.
Perform QC tests in due time according to the team planning and in compliance with effective instructions/procedures and all laboratory/safety procedures.
Ensure the availability of reagents, consumables in due time and assist the QC support in the management of QC reagents stock level.
Perform his/her duties and document his/her work according to Catalent’s current procedures and GMP rules.
Interpret analytical results and warn immediately the QC TL / Supervisor / Manager in case of unusual event/result/OOS.
Participate in troubleshooting of experiment and equipment issues.
Initiate or review deviations, OOS and CAPA linked to QC Bioanalytical platform and lead necessary investigation. Implement CAPA.
Double check filled forms or data generated by QC Experts / Scientists / Technicians, for testing which he / she is trained.
Fill certificates of analysis and ensure that a product will only be released if it’s specifications are met.
Complete data archiving; control charts and all other needed follow-up files.
Participate to the drafting / review of instructions and forms in collaboration with MSAT / P&AD department.
Assist the QC support in daily maintenance of the laboratory (bench and floor cleaning, waste removal, general aspect, etc).
Warn immediately the QC TL/Supervisor/ Manager in case of problem or failure or security issue.
Participate actively to the weekly QC team meeting.
Maintain effective, constructive and positive communication with all QC team members and other departments.
Take part in audits when necessary.

The Candidate (requirements)

Bachelor’s degree or higher in biology, biomedical sciences, biochemistry or clinical chemistry.
Demonstratable experience in cGMP environment and/or quality control is a must.
Strong experience in Bioanalytical is a must
Computer skills: Microsoft Office, MS Teams.
Organization skills, multitasking, flexibility and autonomous.
Teamwork.
Technical expertise in main analytical methods used at Catalent Oxford - all QC platforms combined.
Results oriented; problem solving skills
Quality minded, rigorous and pro-active.
Leadership Competencies

Leads with Integrity and Respect
Delivers Results
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Champions Change
Engages and Inspires
Coaches and Develops
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.