Investigator, Mfg Compliance (Contract)

Position Summary:

Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates. Is knowledgeable and complies with all pertinent safety policies, rules and regulations. Ensure that all team members comply with safety rules and regulations.

The Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA’s for the assigned department. The incumbent is responsible for completion of process deviations with the aim at identification of root cause, determining any product quality impact and implementation of corrective actions to prevent recurrence. They will also be responsible for drafting and managing Departmental Change Controls.

*This is a contract position and will not include ProKidney benefits*

Responsibilities:

• Technical writing for the educated reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
• Gathering Data from various sources across the site, performance of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality, Purity, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.
• Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Work with the appropriate department(s) for data gathering, observing processes for investigations, and performance of associate interviews.
• Meeting Facilitation and participation, aligning internal team and area subject matter experts on an agreed investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
• Understand Regulatory requirements around Cell Therapy processing.
• Able to lead and track Change controls through the process ensuring timely completion.
• Perform other duties as assigned.

Qualifications:

• Undergraduate degree in science discipline
• 5+ years’ experience in a Cell Therapy environment in the department hired.
• Strong organizational skills and record keeping with the ability to work overtime when needed.
• Ability to engage and interview co-workers to obtain relevant information pertaining to investigations.
• Strong attention to detail and organizational skills.
• Strong communication skills (written and oral).
• Independent and self-motivated.
• Familiarity with cGMP quality systems.
• Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).
• Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint).