Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

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

Job Description

Quality on the Floor (QotF) - Fixed Term {6 months}

Summary

Quality on the Floor (QotF) employees are responsible for maintaining the quality and GMP adherence of products, equipment, and processes. They provide real-time Quality expertise on the floor, addressing any customer concerns or partner issues that may arise and taking the necessary actions. They ensure GMP standards are met, verify compliance with standard operating procedures, and support integration of a Quality approach in all our processes. Quality on the Floor Employees have a direct reporting line to Quality leaders.

Key tasks

• Provide active QotF support to manufacturing operations* – by being present on the floor e.g. observing critical processes, performing visual inspection, and offering support in the flow of work.
• Review and provide feedback on documents such as Batch Records, logbooks, and other GMP data/ records while being present on the floor.
• Lead and apply the highest standards of Data Integrity / Good Documentation Practices in our processes e.g. supporting document completeness, accuracy, and compliance (including online review of coordinated LIMS, PIMS and CofA generation or similar)
• Assist in timely resolution for quality-related issues and compliance concerns as a first responder (e.g. part of the RAPID respond team). If any issues or concerns arise, it is important to report them immediately to the Quality Assurance and/or Operations teams.
• Perform daily quality assessments/checks of classified/ non-classified areas to detect errors or deficiencies. Lead by example, always demonstrate a Quality approach.
• Speak up at meetings providing crucial and timely Quality Communications. Contribute to daily operations board and huddle meetings.
• Feedback and mentor in the flow of work for operations employees to enable smooth operations.
• Contribute to self-inspection and process audits on the shop floor and work closely with operations partners and GEMBA colleagues.
• Write, review, and approve documents such as Standard Operating Procedures and Work Instructions.
• Serve as liaison to Quality Culture initiatives and demonstrate Quality Culture in their daily work.
• Prepare technical plans, reports, and protocols as needed.
• Partner with other functions and departments e.g. project management, facilities, and microbiology, to alert them to Quality events.
  

Other key tasks

• Handle batch record efficiency data where relevant e.g. turnaround time, cycle time, backlog, efficiency, document RFT trending if needed.
• Identify and contribute to process improvement initiatives (PPI) and continuous improvement projects.