Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

Job Title: Supervisor, QC Systems

Requisition ID:

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

St. Louis, MO/Biologics Division

How will you make an impact?

The supervisor over QC Systems will be responsible for the day-to-day oversight for all the responsibilities of the QC System Engineers. This team is responsible for a variety of support functions in aid of LIMS, SmartQC, LabX, and other Laboratory Software. This person will provide specified instructions to staff, mentor and trains staff, provide "1st Line Defense" to ensure cGMP compliance, and act as SME for the area.

• Provide leadership to assigned staff by performing the following: leading organizational change; developing and empowering staff; encouraging relationships; putting staff in a position to succeed, meeting their personal career goals while also achieving organizational goals; building effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
• Supervise the status of the routine activities ongoing in team and provide updates to external department(s) and/or leaders as needed. Evaluate and make practical decisions on accepting new workstreams into the team.
• Using a variety of PPI techniques, identify and develop process improvement plans focused on improvements to laboratory and support groups efficiency and compliance.
• Authors, review and/or approve SOPs, protocols and documents related to processes within the laboratory support function.
• Responsible for scheduling of work/tasks within the department.
• Supervise the department's investigations to ensure compliance with the BU's quality standards. Participate in and/or lead root cause analyses for moderately complex investigations and generate/implement CAPAs.
• Represent QC Systems area during regulatory/client audits and on project teams.
• Provide support to site Safety initiatives.
• Other job duties as assigned.

• Minimum of an Associate's degree.
• Bachelor's degree in science related field is a plus but not required.

• Proven experience working in a GMP regulated environment [> 5 years].

• Demonstrated ability working in a Quality Role (QA or QC) [> 5 years].
• Minimum of 1 year of experience in a team lead or supervisor role.
• Minimum of 1 year experience in a role as a superuser or admin of at least one major laboratory software.

• Knowledge of GMP regulations in a GMP environment.
• Knowledge of Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
• Knowledge of Computer Software Validation Lifecycle (CSV) - commissioning, maintenance, periodic review, and decommissioning.
• Familiar with standard project management concepts, tools and responsibilities (objectives, scope, deliverables).

• Able to read, write, and communicate in English.
• Able to use standard computer programs such as MS Excel, Word, and PowerPoint.
• Able to drive functional, technical and operational excellence.
• Able to inspire and cultivate innovation, collaboration, visibility and team effectiveness.
• Able to work in a constantly evolving environment and adapt to a variety of internal customer's needs (laboratory analysts).
• Able to deescalate difficult situations and lead others.
• Able to recognize problems developing, not just occurring and recognize solutions.

• Strong computer, scientific, and organizational skills.
• Strong interpersonal skills including actively listening, conflict resolution and the ability to effectively influence diverse team members for positive outcome.

• A flexible work schedule may be required.
• A flexible (hybrid) work environment may be allowed with prior approval and met performance standards.