Coordinator, Qc Compliance and Continuous
vor 15 Stunden
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
**Purpose and scope of position**
This position is part of the team “Projects, Compliance and Facility” within Quality Control Laboratory of BMS Boudry site.
One of the other main responsibilities of this function is to coordinate change control evaluations by bringing process or activity knowledge and centralizing the assessments from other QC teams impacted in order to define the right actions for implementation.
This role is also a LIMS facilitator for QC laboratories providing support to Analysts/Management, and ensuring collaboration with local/global LIMS Teams. In this way the facilitator will bring his system expertise to solve punctual issues and will follow-up opened incidents. He/She will also organize trainings and coordinate implementation of system improvements according to QC team’s needs.
Being a member of the “QC Projects Compliance & Facility” team, other specific tasks associated to Manager’s responsibilities for regulatory inspections, internal facility management or laboratory compliance can be assigned.
**Skills/Knowledge Required**
- Federal Certificate of Capacity as Laboratory Technician or similar education in Microbiology, Biology, Chemistry, Pharmacy or similar
- Minimum of 3 years of QC experience or related cGMP laboratory experience in the pharmaceutical industry
- Good knowledge of Quality Control Laboratory processes
- Good knowledge of Lean principles and tools, 5S, visual management
- Good knowledge of Project management tools and methodologies
- Good technical writing skills and verbal communication skills
- Good proficiency in common office software
- Good knowledge of solid oral dosage forms (capsules and tablets) analytical methods
- Fluent in French and professional command of English (verbal and written)
- Skilled in organizing, planning, priority setting and time management
- Takes a structured and analytical approach to problem solving
- Ability to work collaboratively and cross-functionally with peers
**Duties and Responsibilities**:
**Act as** a representative of Project management and Continuous improvement**
- Support other QC team members for projects or internal initiatives to ensure progress and escalate issues observed to the management
- Lead specific QC projects
- Implement improvement initiatives
- Give visibility to QC initiatives and centralize gains
- Lead 5S program and support 5S area owners
**Maintain Compliance in accordance with global cGMP regulations and BMS policies**
- Coordinate change control evaluations and action assignments within the teams
- Support regulatory inspections and internal audits, and follow-up associated actions
- Support risk assessment initiatives as QC expert for specific processes
**Act as** a LIMS implementation facilitator**
- Provide system trainings to future users
- Support QC members in routine issues providing system expertise
- Coordinate with Laboratory, CELabs and Global IT teams for incidents and improvements
- Perform dry runs and User Acceptance Testing
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.
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