Senior Scientist, Quality Control Compliance Microbiology
The Senior Scientist QC Compliance Microbiology will work both independently and with the team overseeing all the QC microbiology-related compliance records across Deviations, CAPA's and Change Control. This role will be primarily responsible for providing technical assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis-driven investigational testing plans. In addition, this role will work closely with the Lab Excellence team on areas for improvement.
This position is part of the Summit Quality Control Compliance Team, which is comprised of two pillars: Compliance and Continuous Improvement. While this is a site-based role, collaboration across other sites in the CTDO network and the BMS Global network is essential.
· Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
· Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
· Follow directions properly, work cooperatively as an individual contributor and as a team member.
· Communicate effectively with QC peers, cross-functional peers and management.
· Must have strong microbiological technical skills to provide assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis-driven investigational testing plans.
· Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
· Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
· Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
· Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
· Carry out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
· Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
· Follow directions properly, work cooperatively as an individual contributor and as a team member.
· Communicate effectively with QC peers, cross-functional peers and management.
· Must have strong microbiological technical skills to provide assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis driven investigational testing plans.
· Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
· Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
· Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
· Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
• Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
• Requires minimal direction to complete more complex tasks.
• Comfortable providing input/guidance to others within the department and across the organization in deviations technical writing.
• Strong knowledge of problem-solving methods used to perform Root Cause Analysis
• Propose solutions for issues and work with management to resolve.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to support internal and health authority inspections of facility.
• Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports as needed.
• Support investigations and CAPAs associated with QC Department.
• Support data trending and tracking of results and draw conclusions from said data.
• Take ownerships/accountability of assigned tasks and come up with solutions/improvement suggestions.
• Perform all other duties as assigned by Management.