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.
Position Summary
BMS Cruiserath Biologics is seeking to recruit a Senior specialist, QA Technical Operations, Drug Substance. This is a 12 month fixed term contract role.
Reporting to the Senior Manager, QA Technical Operations, Drug Substance, the Senior specialist will support investigations within the Multi Product Cell Culture (MPCC) and supporting areas. The Senior specialist, QA Technical Operations will also be responsible for supporting qualification and validation activities, as well as New Product Introductions (NPI) and technical transfers. The role will support Engineering, Warehouse, Facilities, Utilities and Automation activities while also providing support for SAP, Maximo and Manufacturing Execution System (MES).
The role will be both challenging & rewarding and will ensure that the successful candidate can seize a wide range of development opportunities within BMS.
Key Responsibilities
Support review and approval of investigations within MPCC and supporting areas.
Facilitate the investigation triage business process and the daily investigations meeting.
Author, review, and approval of QA related procedures.
Support implementation of site initiatives to prevent deviation recurrence.
Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s.
Provide QA support for change controls, Projects, NPI and Tech Transfer Projects.
QA support for Maximo, Service Now, ALM and SAP related activities.
Provide QA support for site validation and qualification activities.
QA review and approval of Annual Product Quality Review reports (APQRs)
Review and approval of GMP documentation, including validation plans, protocols, reports, SOPs, forms, directives, policies and other validation documentation as required.
Drive and support a culture of continuous improvement initiatives and safe working practices.
Qualifications & Experience
The successful candidate must possess:
BSc in Science or a related discipline, with a minimum of 3 years Quality or related experience in the biopharmaceutical industry.
A clear understanding of cGMP requirements for areas of responsibility.
Demonstrated knowledge of deviation and change management processes.
Required to work on his/her own initiative in addition to working as part of a team. Must be capable of working across a team matrix to meet accelerated timelines.
Capable of positively influencing others to bring resolution to complex issues.
Excellent communication and presentation skills are essential.
Excellent time management and organizational skills along with a proven ability to multi-task.
Demonstrated ability to recognise issues, highlight risks and prioritise workload based on site goals and objectives.
Employees are expected to display the BMS values and behaviours, which enable them to be successful and perform at their highest level.
Why you should apply
You will help patients in their fight against serious diseases
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
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