QA Systems & Compliance Intern

At Bristol Myers Squibb, our employees often ask, "Who are you working for?" - a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

Inspire and be inspired. We offer a variety of opportunities for undergraduate and post-graduate students to use your talent, skills, education and passion to help make an impact on patient's lives - all while growing your career and earning academic credit.

Our Internship Programme gives you a real opportunity to gain practical 'hands-on' experience, training and shadow the experts of your chosen field. It also provides you with insight into what it's like to work with us.

We will place you in a six-, nine-, or twelve-month Internship Programme depending on the requirements of your degree course. So, are you ready to embark on a new adventure? We can't wait to see what you're made of!

Bristol-Myers Squibb is seeking to recruit a QC Intern, Contract laboratory Management to join the QC Materials team at its Multi-Product Cell Culture Drug Substance Facility in Cruiserath, Dublin.

Reporting to the QC Contract testing Senior Manager they will be responsible for supporting site activities related to Sample Management Laboratory, in-process samples, and laboratory duties in accordance with cGMP regulations.

The main responsibilities for this position include;

Management of contract test laboratories (CTLs):

•Assist in the management of contract test labs and tech transfer project management. •Data entry in laboratory electronic systems e.g. LIMS •Assist in the management of method and specification updates and change control impact assessments for QC. •Support QC Investigations/Deviations and change controls •Liaising with BMS local and global stakeholders and external providers •Participate in the OpEx strategy and support process improvements •Prepare and process QC documentation in quality documentation management system. •Participate in QC Materials ad-hoc activities as required to support QC.

• Support change controls/child actions for implementation of all changes affecting CTLs as required
• Provide accurate forecasting for the CTLs.
• Author, review and approve documentation where required.
• Manage the BMS relationship with CTL.
• Escalating and addressing any issues with the CTL.
• Assist in continuous improvement activities involving CTLs.

Compendial Updates/Change Control Impact Assessments:

• Inform relevant groups (e.g.: bioassay or raw materials) on the proposed/implemented changes.
• Support completion of impact assessments.
• Gather feedback from all areas impacted by changes.
• Close all owed child action within the target dates.
• Provide feedback to global Compendial Affairs team within the due

Date.

• Assist in the update of relevant local procedures if applicable.

Other responsibilities:

• Provide technical support to QC Cruiserath Biologics on the establishment of laboratory procedures, practices, quality systems and troubleshooting analytical issues if required.
• Maintain a high standard of GMP compliance including the completion and provision of training as required.
• Maintain safe working environment in laboratories and own area.
• Take ownership of topics as appropriate during regulatory and global inspections.
• Provide support to regulatory filling submissions.
• Support introduction of Operational Excellence strategy at BMS Cruiserath.
• Support the generation of protocols, reports and risk assessments.

The successful candidate must demonstrate good written and verbal communication skills, attention to detail, ability to meet deadlines and the ability to work in a team based collaborative environment.

The ideal candidate should be enrolled in an appropriate 3rd level course .

We hire for skills and capabilities, not just credentials - if this role excites you, but doesn't perfectly match your resume, we encourage you to apply anyway.