Investigator, MFG Compliance

ProKidney•Winston-Salem, NC

About The Position

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. 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 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.

Requirements

Undergraduate degree in science discipline
5+ years’ experience in a Cell Therapy environment in the department hired
Strong organizational skills and record keeping
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)
Eligible to work in the United States without the need for work visa or residency sponsorship

Responsibilities

Initiate, investigate, and complete process deviations, Change Controls, and CAPA’s.
Identify root causes of process deviations and determine product quality impact.
Implement corrective actions to prevent recurrence of deviations.
Draft and manage Departmental Change Controls.
Translate scientific events into brief and cohesive reports.
Accurately capture immediate actions and containment of events.
Address comments from internal and external clients on compiled reports.
Gather data from various sources across the site.
Perform Root Cause Analysis.
Assess events for impact to Safety, Identity, Strength, Quality, Purity.
Perform trending analysis.
Identify Corrective and Preventative Actions.
Perform Risk Assessments, Causal Mapping, and Interviewing.
Manage multiple projects and timelines concurrently.
Adhere to standard timelines and escalate actions appropriately.
Work with appropriate departments for data gathering and process observation.
Perform associate interviews.
Facilitate meetings and align teams on investigational paths.
Resolve conflicts and solve problems in a cross-functional setting.
Keep meetings on track to achieve objectives.
Understand Regulatory requirements around Cell Therapy processing.
Lead and track Change Controls through the process.
Perform other duties as assigned.