QA Intern

WuXi Biologics•Dundalk, MD

About The Position

QA Intern The QA Intern will support the Quality Assurance team and gain hands-on experience in quality assurance activities 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.
Knowledge and understanding of biopharmaceutical processes.
No previous experience required, demonstrated ability to work in teams through university/college activities.
Currently pursuing a third level undergraduate or post graduate qualification in a relevant Science or discipline.
Knowledge and understanding of biopharmaceutical processes.
Good communication skills required as QA Intern will be required to work with cross functions.
Excellent communication and problem-solving skills.
Have a passion to grow and develop your career.
Flexible attitude and positive mind set.
Desire to be part of a successful team and innovative environment.

Nice To Haves

Experience in Microsoft applications (Outlook, PowerPoint, Excel, Word etc.) is an advantage.

Responsibilities

Review batch production records, including liaising with other QA teams or other departments, such as Manufacturing and Supply Chain/ Warehouse, to resolve any discrepancies noted during the review.
Support the DS QA and WH QA in provision of online support for Manufacturing and Warehousing activities.
Support the DS QA and WH QA investigating quality related deviations.
Support batch record review metrics including maintenance of the batch record review tracker.
Preparation of batch disposition documentation.
Compilation of batch disposition packs.
Organisation, scanning and filing of batch paperwork.
Support controlled document issuance, as required.
Support the Quality Monitoring program in Warehouse and Manufacturing areas.
Support the GMP Release program in Manufacturing and Warehouse areas.
Support Client Audits and Health Authority Inspections, as required.
Support drafting and revision of SOPs relating to QA Operations team, as required.
Perform all duties in accordance with GMP requirements, SOPs, and controlled documents.
Will be flexible to take on additional tasks and responsibilities at the discretion of the QA Lead DS Manufacture and QP.