QC Specialist – Compliance
vor 1 Tag
Client: Bristol Myers Squibb
Location:
Job Category: Other
Job Reference: 048f77ab30bc
Job Views: 12
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:Working with Us
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.
This position is part of the team “Compliance & Continuous Improvement” within the Quality Control Laboratory of BMS Boudry site.
The Specialist QC “Compliance & Continuous Improvement” supports the program implemented by the Manager to maintain a reliable, qualified, and regulatory compliant operation with a project and continuous improvement strategy for Boudry QC Laboratory.
The QC Specialist – Compliance & Continuous Improvement will be required to support inspections (including but not limited to internal, corporate, and regulatory audits) and QC Management to fix associated observations.
This role will be the point of contact to coordinate specific system enhancements, to manage isolated issues, and to provide or coordinate training.
As a representative of continuous improvement and experienced collaborator, the Specialist drives specific initiatives and supports Sr Specialist or other QC members for specific activities which aim to continuously increase QC Laboratory compliance and performance.
Key Responsibilities
- Support Compliance in accordance with global cGMP regulations and BMS policies
- Support regulatory inspections and internal audits
- Assist in the implementation of associated actions
Act as QC representative for Projects or support implementation
- Bring technical & process knowledge to ensure proper Projects implementation
- Participate in cross-functional meetings
- Communicate and escalate main information or issues highlighted
- Execute specific tasks according to Projects needs
Support Continuous Improvement initiatives within laboratories
- Maintain QC performance data tools implemented
- Implement actions defined as part of performance data analysis
- Gather and report data for KPIs
- Support implementation of LEAN programs (5S, Gemba, Pareto, Tiers, Gemba …)
- Support QC improvement initiatives
Qualifications & Experience
- Federal Certificate of Capacity as Laboratory Technician or similar education in Microbiology, Biology, Chemistry, Pharmacy or similar.
- Preferred to have a minimum of 2 years of QC experience or related cGMP laboratory experience in the pharmaceutical industry
- Knowledge of Lean principles and tools (5S, Pareto, Visual management, …)
- Knowledge of data collection and data analysis
- Good technical writing & verbal communication skills
- Good proficiency in common office software
- Fluent in French and professional command in English (written and verbal)
- Abilities in organizing, planning, priority setting and time management
- Ability to work collaboratively and cross-functionally with peers
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.
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