QC Operations Team Lead

at  WuXi Biologics

As QC Operations Team Lead (FTC – 12 months), you will be responsible for will be responsible for carrying out tasks and projects relating to QC instruments/equipment, computer systems, sample management, and general QC-compliance functions while ensuring the highest standards of Good Laboratory Practices, regulatory requirements and quality within the business is adhered to. As part of the project the role will evolve based on project timelines.

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 provide our clients with a world-leading open access technology platform. 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. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

DEPARTMENT DESCRIPTION

As QC Operations Team Lead (FTC – 12 months), you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the Associate Director of QC Operations.

EXPERIENCE

• Experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
• Previous experience managing and leading a small team would be advantageous.
• Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.
• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.
• Management/supervision of personnel with particular attention to schedules and shifting priorities is desirable.
• Previous experience working in a CMO is an advantage.

KNOWLEDGE

• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory. Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.

QUALIFICATIONS

• University degree in related science/quality discipline required.

ONEROUS REQUIREMENTS

• May be required to travel to fulfil duties of the role.
  As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential!
  If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don’t miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

• Key member of the QC Team in Dundalk. Will support execution of the strategy and business planning processes, ensuring cross-functional collaboration.
• Achieve a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.
• Perform routine and non-routine testing activities as required.
• Ensure that all testing is completed, reviewed and approved within agreed turnaround times.
• Providing day to day operational & training support for laboratory systems such as LIMS and Empower.
• Ensure QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Train other QC analysts and Manufacturing personnel in laboratory methods and procedures when required.
• Write/update and review TMs (Test Methods), SOPs (Standard Operating Procedures) and WIs (Work Instructions) as required.
• Write and review invalid tests, non-conformances and deviations as required.
• Initiate and drive change controls to completion to implement process improvements.
• Actively participates in lean initiatives such as Kaizen, 5S and Gemba.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of QC Operations.
• Potential candidates may be required to carry out additional job functions that are not described in this job description but will be associated with the role.