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QC Specialist/ QC data administrator
vor 3 Monaten
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
This position is part of the team Compliance & Continuous improvement within Quality Control Laboratory of BMS Boudry site.
The Specialist QC data administrator will be in charge of the implementation of SmartQC software to support the development and maintenance of QC scheduling and planning for drug product, drug substance, packaging items, PPQ and trial material testing on site.
As a data management expert, this role is also responsible to support electronical data management for LIMS system (Labware).
This requires partnering with QC network, system superusers, Information Technology teams, all levels of laboratory personnel and Laboratory sub-teams to ensure the process is designed and maintained for the laboratory personnel to meet testing requirements and commitments with operational efficiency in mind.
The Specialist QC data administrator will also be required to support inspections (including but not limited to internal, corporate, and regulatory audits) and QC Management to fix associated observations.
Key Responsibilities
Implement and maintain SmartQC software
- Develop, maintain, monitor and implement updates to data center tables (including new user setup).
- Add new users to smart QC, indicating appropriate qualifications, work centers, shifts, etc.
- Enter data for long-term and short-term forecasts.
- Collect data.
- Facilitates issue resolution (deep dives to understand why issues occur) and escalate as needed.
- Request and support for data updates in different electronical systems.
- Provide support for Laboratory personnel (Training, Incident management, ...).
- Monitor interface between input systems (LIMS) and tool, including managing LIMS errors at the site.
- Provide support for reporting capabilities: setup the correct reports going to the right level of leader in the organization at the right frequency.
- Periodically verify data such at HOT times, campaign size, etc. which will impact planning and scheduling.
- Periodically verify data such as time spent on unavailable tasks.
- Provide data to leaders in the organization to identify opportunities for CI and/or to verify impact of CI initiatives.
- Coordinate with LIMS team to ensure LIMS updates do not have unintended/unpredictable impacts.
- Maintain QC lab floor presence, ensuring that continuous feedback from all levels of the org is documented and that the scheduling and planning system reflects current practices.
- Provide regular input to QC management regarding QC performance, and identify opportunities for improvements based on data.
- Support electronical data management for LIMS system
- Promotes safe practices and behaviors
- Reports immediately all incidents to EHS, participate in investigations and identify measures to prevent similar accidents in the future.
Qualifications & Experience
- Minimum B.S. degree in a relevant scientific, computer or engineering program area with at least 3+ years' experience (or equivalent).
- Knowledge and in depth understanding of analytical techniques preferred.
- Proficient knowledge of a lab system such as Smart QC, LIMS, ERP, etc., understanding of system management, system interfaces and impact of changes to each other.
- Proficient knowledge and understanding of Microsoft Office Applications (Excel, Project, PowerPoint, SharePoint, Teams, Word) and/or other relevant software programs.
- Demonstrated ability to work independently to complete assignments within defined time constraints.
- Ability to execute changes in the lab system independently, proactively identify problems, troubleshoot issues, and develop potential solutions.
- Ability to troubleshoot issues identified and determine root cause.
- Ability to interpret and apply cGMPs, regulatory requirements, and industry best practices.
- Ability to exercise judgment and makes sound decisions within generally defined practices and policies to independently develop approach/solution. Consult with technical if needed.
- Demonstrated ability to effectively train and assist other less experienced individuals.
- Fluent in French (preferred) and good English skills (verbal and written).
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
