QC Trending & Projects Lead – Digital Scheduling

Bristol Myers Squibb; Cruiserath; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Annual bonus

Pension contribution

Family health insurance

27 days annual leave

On-site gym at BMS Cruiserath

Life assurance

Job summary

Bristol Myers Squibb in Cruiserath, Ireland seeks a QC Trending Analyst to drive APQRs and trend reporting within a GMP environment. You will contribute to performance monitoring, assess trends with SMEs, and manage product additions to the trending programme as part of the Cruiserath QC teams. The role requires a B.Sc.

in Biochemistry or related field, 2+ years GMP lab experience, strong communication, and teamwork skills. Knowledge of Smart QC and project management is desirable.

Qualifications

• Minimum B.Sc. in Biochemistry, Pharmaceutical Science, or a closely related discipline.
• At least 2 years' experience in a GMP laboratory environment, ideally within a biologics setting.
• Demonstrate excellent written and verbal communication skills and experience of working with teams and influencing decisions.
• A strong knowledge of laboratory operation, in particular training and testing requirements from receipt to CoA is required.
• Proven ability to work flexibly within a team environment and adapt to changing business needs

Responsibilities

• Define, schedule, coordinate, and drive activities required for completion of all Annual Product Quality Reviews (APQRs) and annual trend reports.
• Contribute to the Cruiserath Method Performance Monitoring Programme, incorporating reference standard monitoring and invalid rate tracking.
• Conduct trend assessments in collaboration with relevant SMEs, ensuring outcomes are clearly documented and actioned.
• Manage the addition of new products to the trending programme following successful transfer to the Cruiserath QC teams.
• Approve SOPs, trend data, non-conformance reports, and related documentation in accordance with GMP requirements.
• Support and execute activities in line with QCSAS roadmap for QC Trending and digital scheduling using Smart QC.
• Support Lean labs and automated scheduling tool process improvements and project management within the QC Projects portfolio.

Skills

Communication skills

GMP experience

Teamwork

Lab operations knowledge

Data analysis

Education

B.Sc. in Biochemistry or related

Tools

Smart QC (SQC)

Job description

Bristol Myers Squibb in Cruiserath, Ireland seeks a QC Trending Analyst to drive APQRs and trend reporting within a GMP environment. You will contribute to performance monitoring, assess trends with SMEs, and manage product additions to the trending programme as part of the Cruiserath QC teams. The role requires a B.Sc.

in Biochemistry or related field, 2+ years GMP lab experience, strong communication, and teamwork skills. Knowledge of Smart QC and project management is desirable.