The Supervisor, Quality Control (QC) Operations position, leads a team of QC associates that executes sample management activities including control, receipt, and distribution of product, intermediates, raw materials samples, sample retention, reference samples, and stability samples at Fujifilm Diosynth Biotechnologies California (FDBC). The QC Supervisor will interact with internal QC, Manufacturing, Quality Assurance, Warehouse and Facilities. In addition to external Quality representatives supporting client requests and/or notifications.
This position is expected to carry out all their activities in compliance with FDBC Quality processes, the requirements of the Quality Management System, and in compliance with regulation requirements governing laboratory controls and manufacturing. The ideal candidate demonstrates technical breadth to support sample management in a laboratory environment. Individuals in this role are very independent, well organized, self-motivated, and are expected to communicate effectively.
- Support the set up and qualification of a GMP compliant QC sample receipt, retain, and distribution system.
- Manage, coach, and develop team of QC associates.
- Author, review, approve, and execute Sample plans and program SOPs.
- Serve as QC Sample Management subject matter expert during internal and external inspections and audits.
- Serve as owner of Quality System records (Deviations, CAPAs, Change Controls) in Veeva.
- Support activities and documentation related to corrections, corrective actions, and preventive actions to mitigate impact and eliminate reoccurrence.
- Attend the Work Center Team (WCT) meetings to discuss ongoing work and issues escalations.
- Perform annual QC sample inventory management and review.
- Execute sample management activities in LIMS.
- Support projects related to implementation of new products within LIMS to automate the QC sample management activities
- Establish routine operations to govern activities in the QC sample management. Routine activities include scheduling sample shipments, ordering supplies, overseeing equipment maintenance and calibration, performing documentation reviews, and escalating any issues appropriately.
- Prioritize and deliver QC sample management tasks and projects per given timeline. Escalate to QC management for delays, issues and support required for completion of given task/projects.
- Review current QC sample management processes, workflows etc. and propose solutions for leaner and better support model.
- Work on other QC Operations project activities as requested by QC management.
- Staff management Scheduling, timesheet approval, invoice approval, issues resolution
- cGMP experience.
- Advanced knowledge of sampling plan lifecycle and inventory management
- Working knowledge of document management and lifecycle
- Working knowledge of quality systems and their interconnections (e.g., LIMS and document revisions)
- Advanced knowledge of how to control, request, receive and/or distribute product/samples
- Basic knowledge of product testing, data analysis, and reporting
- Advanced knowledge of computer systems (e.g., Word, Excel, LIMS)
- Working knowledge of regulations and inspection/audit readiness
- Advanced knowledge of QMS (CAPA deviation change control, laboratory investigation)
- Experience leading people and/or projects with history of achieving results and outstanding outcomes.
- Experience implementing and overseeing sample management programs.
- Proficient time and project management skills.
- Experience in a cell/gene therapy cGMP manufacturing and testing facility is a plus.
- Proficient competencies include communication, risk management, conflict resolution, teamwork & collaboration, decision making, people management, and strategic leadership.
- Advanced competencies include problem solver, critical thinking, customer service oriented, and goal/results oriented.
- Must be able to work in controlled environments requiring special gowning for biosafety and radiation laboratories.
- Must be able to work in a flexible and dynamic environment, with potential to work in shift schedules to meet business need.
- Flexibility to travel as required to accommodate the needs of the business.
Subject to extended periods of sitting and standing, vision to monitor and moderate noise levels. Work is performed in a laboratory environment and includes use of LN2 freezers and lifting/movement of racks of sample boxes.
EDUCATION AND PROFESSIONAL EXPERIENCE
- 0 –2 years of team management experience
- Bachelor of Science (B.Sc.) with 5+ years of experience or an equivalent combination of education; or Master of Science (M.Sc.) with 3+ years of experience; or PhD in Science with 0-3 years of experience
TRAVEL Limited Travel (up to 10%).
SALARY AND BENEFITS
- $46 to $51 per hour, depending on experience.
- Medical, Dental, Vision
- Life Insurance
- Paid Time Off