Job description:
QC Intern
The QC Intern will support the Quality Control team and gain hands-on experience in quality control manufacturing processes while helping ensure compliance and product quality.
Your Responsibilities:
- Sample management – Receiving samples from manufacturing and distributing them to the correct labs on request. Receiving shipments of samples from other sites (storing them correctly / Relabelling them with correct information).
- Ensure following the requirements of EudraLex cGMP guidelines.
- Present daily team meetings to discuss the day ahead and any issues which need to be addressed.
- Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
- Support and lead QC test method validation and development of routine testing strategies when required.
- Update clients on method transfer/validation progress of projects
- Routine laboratory testing of raw materials, in-process and stability samples, DS and DP, reporting and review of data.
- Troubleshooting any equipment issues (HPLC, GC, UPLC, UV Spec).
- Regular review of documentation and process equipment calibration logbooks, documentations, and software processes. Also organising all paperwork and logbooks are stored in the correct areas.
- Support project management activities, including timeline tracking, resource allocation, and milestone achievement.
- Will be flexible to take on additional tasks and responsibilities at the discretion of the QC Director.
- Will act as a role model for the Quality function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Your Profile:
The ideal candidate for this position will have the following:
Qualifications
- Pursuing a third level undergraduate or post graduate qualification in a relevant Science or discipline. For example, but not limited to: Analytical Chemistry, Biochemistry, Biology, Biological Sciences, Biotechnology, Microbiology, Pharmaceutical Science.
Knowledge/Experience
- Familiarity with current Good Manufacturing Practices (cGMP) and regulatory requirements in the pharmaceutical industry.
- Familiarity with data analysis and visualization tools (e.g., MATLAB, R, Python) is a plus.
- Proficiency in data analysis tools and software commonly used in bioprocessing.
Technical Competencies
- Understanding of bioprocessing principles, including upstream and downstream processing techniques.
- Ability to analyse complex data sets and draw meaningful conclusions.
- Problem-solving skills with a focus on identifying and addressing root causes.
Behavioural Competencies
- Excellent written and verbal communication skills.
- Ability to articulate ideas and findings clearly and concisely.
- Comfortable collaborating with cross-functional teams and presenting information to various stakeholders.
- Demonstrated ability to work collaboratively in a team-oriented environment.
- Willingness to contribute actively to team discussions and share insights.
- Strong attention to detail, ensuring accuracy in data analysis and documentation.
- Commitment to maintaining high-quality standards in all aspects of work.
- Ability to adapt to a dynamic and fast-paced work environment.
- Openness to learning new technologies and techniques in bioprocessing.