QC Intern

WuXi Biologics•Dundalk, MD

About The Position

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. Organization Description: WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide.

Requirements

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.
Familiarity with current Good Manufacturing Practices (cGMP) and regulatory requirements in the pharmaceutical industry.
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.
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.

Nice To Haves

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.

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.